The Technical Associate Director (AD) is responsible for the oversight of all technical operations and scheduling and planning for the manufacturing department.  The Technical AD is accountable for ensuring a quality driven, efficient, robust, and safe process, while continuously challenging inefficiency and process loss at every opportunity. The Manufacturing Technical AD will lead a cross-functional team and utilize relationship building skills to develop a culture of success through coaching, mentoring and strong personal leadership

Duties/Responsibilities:
•    Oversee all manufacturing technical functions and collaborate with partners and customers, such as MT and MST, to achieve MFG deliverables including continuous improvement projects (yield increases), COGs reduction, lean manufacturing, schedule adherence, and facility upgrades and enhancements.
•    Through the use of advanced scheduling systems and tools, maximize schedule adherence, build standard process models, optimize real time scheduling, and implement CAPA action plans as needed.   
•    Interact regularly and collaboratively with both internal and external customers to effectively resolve MFG issues.
•    Oversee the investigation and execution of low risk Quality Events to support manufacturing operations and provide support for medium and high investigations where required. 
•    Facilitate the authoring of minor equipment and facility change controls, MBR revisions, and CAPA Action Plans
•    Lead and manage project plans, spending, personnel, and schedules of MFG specific projects according to deliverables and overall priorities
•    Drive strong collaboration and communication across MFG, Quality, MS&T/MT, Analytical, and Product teams to ensure projects meet all objectives and timelines.
•    Identify process improvement opportunities and implement process changes and improvements through quality systems. 
•    Support the site in project evaluation and provide technical inputs to potential projects
•    Provide support for regulatory inspections, observations, and risk assessments
•    Ensure proper process and validation support.
•    Develop strategy and objectives for the group to meet the site’s strategic goals
•    Provide coaching and mentoring. Regularly met with staff to discuss performance and career development. 
•    Conduct personnel and team performance management through objective setting, performance appraisal reviews and succession planning.  
•    Remain current on up-and-coming technologies, scientific breakthroughs, novel concepts and regulatory trends.

Qualifications:
Specific Knowledge, Skills, Abilities, etc

•    Proven leadership skills and track record of success in managing technical groups (direct reports) and teams (matrix environment)
•    Excellent project team management and matrix system skills
•    Excellent verbal communication, documentation and technical writing skills
•    Demonstrated experience in cell culture, purification and analytical sciences for producing clinical and commercial biopharmaceuticals
•    Proven records and ability in productivity improvements and cGMP biologics manufacturing
•    Familiarity of regulatory issues pertaining to the manufacture of biologics, large scale biopharmaceutical unit operations and process validation
•    Demonstrated creative problem-solving skills under resource constraints and time pressure
•    Strong technical problem-solving abilities, written and verbal communication skills.
•    Demonstrated leadership skills in coaching, managing and mentoring new staff members
•    Demonstrated success of leading effectively in a complex matrix project team environment.

Education/Experience/ Licenses/Certifications: (list required education and experience, along with any additional education/experience/qualifications that are preferred)
•    Knowledge of science generally attained through studies resulting in a M.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
•    Direct biologic manufacturing experience of 10+ years with minimum of 5+ years of previous supervisory experience which demonstrates proficiency in selection of team and effectively managing personnel issues is required.
•    Extensive knowledge of SOPs and GMPs and the know-how to work and manage within a regulated environment
•    Strong knowledge of biopharmaceutical manufacturing processes with a proven record in biopharmaceutical technology
•    Strong change management skills and demonstrated ability to simplify and improve business processes
•    Excellent leadership skills with the ability to motivate and manage a team with matrix reporting relationship
•    Adaptable to a fast paced, complex and ever-changing business environment
•    Effective verbal and written communication skills with technical writing skills
•    Proficiency in the use of computers and business software applications 
•    Yellow or green belt certified in lean manufacturing/operational excellence

Physical Demands / Work Environment: 

This a managerial position in a manufacturing facility with classified areas requiring appropriate gowning and personal protective equipment (PPE).  This role will require working around hazardous conditions and materials such as caustic, acids and steam.  Powdered materials and high temperature liquids are also handled in the respective areas.  

Supervisory Responsibilities:

Will supervise a direct staff of 4-10 employees with department level managerial responsibilities.

Summary

The Senior Manager, Clinical Data Management (Data Management Lead) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Director, Clinical Data Management or Associate Director, Clinical Data Management (Line Manager) within the Global Data Management and Centralized Monitoring function of Global Clinical Operations (GCO).

This is an office-based position located in Central New Jersey, USA

Specifically, the Sr.Manager, Clinical Data Management (Data Management Lead) is accountable for:

Providing leadership of clinical data management activities across one or more clinical development programs enabling planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.

A key role (Data Management Lead) that serves as the primary point of contact to the wider clinical trial team for clinical trial data related matters. The DML will, in turn, coordinate activities across clinical data management, clinical data acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting.

A consistent approach to the gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards, and also responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness at all times.

Leading activities with external vendors developing systems/applications for clinical trial data collection (e.g. ePRO/eCOA) to ensure quality and timely deployment.

Implementation of the Data Quality Management Plan (DQMP) defining and documenting the data quality review strategy for each clinical trial in collaboration with various BMS stakeholders (e.g. statistics, medical, safety, development, GCO, etc.), enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities.

Supporting clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs/ePROs/eCOAs.

Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing data management services on behalf of BMS.

Contributing to the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.

Participating in continuous improvement activities, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to data management.

Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Experience and expertise required

Bachelor’s degree required with an advanced degree preferred. At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.

Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.

An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).

Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

Experience in data management and well versed in industry trends and emerging industry dynamics concerning data review.

A good understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).

Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.

Leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

Summary

Providing leadership of clinical data management activities across multiple clinical development programs, overseeing a team of clinical data management professionals in planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.

Effective coaching and mentoring of Data Management Leads (DMLs) and other clinical data management staff in the team to ensure consistently high levels of performance and productivity in support of various clinical trial teams.

Strong coordination of activities across clinical data management, clinical data acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting.

Roles and Responsibilities

Assignment of staff, providing support and guidance as needed, and working with peers to ensure consistent approaches in-

Gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards.

User acceptance testing to ensure high quality deliverables and inspection readiness at all times.

Implementation of the Data Quality Management Plan (DQMP) defining and documenting the data quality review strategy for each clinical trial in collaboration with various BMS stakeholders (e.g. statistics, medical, safety, development, GCO, etc.), enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities.

Supporting clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs/ePROs/eCOAs.

Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing data management services on behalf of BMS.

Contributing to the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.

Focusing on continuous improvement, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards.

Leading a multi-national team of clinical data management professionals that contribute significantly to BMS portfolio of clinical trials. Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empowers and holds staff to high quality performance and delivery of the business.

Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to data management.

Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.

Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.

Experience and Expertise Required

Bachelor’s degree required with an advanced degree preferred. At least 7 years of relevant industry experience, with experience of managing staff in a global setting. Project management certification (e.g. PMP) is desirable.

Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.

A good understanding of database and dictionary structures (e.g. MedDRA, WHODrug).

Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

Experience in data management and well versed in industry trends and emerging industry dynamics concerning data review.

A good understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).

Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.

Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

Working in a cross-functional virtual plant team this quality associate manager provides quality oversight of Contract Manufacturing Organizations (CMOs).  Primary responsibility is to support management of CMO disposition documentation, assure CMO compliance with BMS and applicable cGMP and international regulatory standards for biologics drug substance and drug product manufacture, testing, and distribution.

Key Accountabilities:

• Perform product disposition activities to ensure the timely supply of drug substance, drug product, and finished product that meet commercial customer requirements while ensuring compliance with testing standards, SOPs, validation guidelines and regulatory filings.
• Author, compile and maintain documentation needed for disposition of the product from Contract Manufacturing Organizations (CMOs)
• Review disposition documentation from CMOs and recommend disposition, escalating potential issues
• Ensure batch documentation relative to CMO materials and products is maintained and archived
• Input required deviation, complaint, change control, and product disposition information into applicable enterprise systems
• Prepare and review of Quality Agreements with external manufacturers and external laboratories
• Manage quality metrics in relation to CMO performance
• Assist in preparation of Annual Product reviews as required for end to end product monitoring
• Work with CMOs to ensure PAI readiness plans are appropriate, and corrective actions are tracked to completion
• Assist with reviewing analytical and method protocols and reports for compliance
• Assists analytical lead for method test transfer and revision documentation
• Provide quality support during self-inspections, internal audits, and regulatory agency inspections at contract manufacturers.
• Support supplier relationship manager, global procurement, supply chain and manufacturing science and technology teams for new projects, technical transfers programs, supplier selection programs, and commercial manufacturing activities
• Review validation documents, deviations, and change controls and escalate any potential compliance gaps
• Escalate issues to senior management to ensure that issues are resolved to support BMS business and compliance requirements
• Evaluate external quality complaint investigations provided by CMOs

Required:

• Minimum B.S. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
• Minimum of 4 years’ experience in pharmaceutical operations at the manufacturing site
• At least 2 years in Quality, ideally in product release or pharma project quality
• Experience in aseptic, sterile and biological drug product manufacturing
• Experience in contract manufacturing or contract testing
• Good verbal, written and presentation skills in English, understanding of German is desired
• Experience with technical writing, ideally authoring investigations, quality risk assessments, process descriptions, or study protocols

Ideal Candidates Would Also Have:

• Ability to negotiate and clearly present complex topics both in written and verbally
• Knowledge of combination products manufacturing or finished drug product packaging
• experience with biological product testing methods/quality control
• Experience with GMP tools and standard applications: SAP, Trackwise or Verity, MS Office (esp. OneNote, Visio)

Bristol-Myers Squibb (BMS) is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Bristol-Myers Squibb has built a new state-of-the-art Multi-Product Cell Culture (MPCC) biologics manufacturing facility in Ireland, Cruiserath, Dublin 15 - a $1 billion investment. This new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network.

BMS Cruiserath Biologics is seeking to recruit a permanent A&IT PAS Systems Infrastructure Engineer. Reporting to the A&IT PAS Infrastructure Technical Lead, the A&IT PAS Systems Infrastructure Engineer is required to support the installation, configuration and support of the IT Infrastructure associated with Process Automation Systems.

Key Duties and Responsibilities:

• Support the administration of Process Automation Systems IT Infrastructure including Server and networking equipment.
• Provide troubleshooting and hands-on support to resolve technical issues.
• Daily operations and sustaining 24/7.
• Participate in the turnover process to ensure compliance with BMS standards. 
• Making improvements to, and offering advice about, installation and configuration procedures.
• Scheduling and coordinating work to tight deadlines.
• Ensuring that equipment works to its specification.
• Creating and carrying out test procedures.
• Writing reports and documentation.
• Providing technical support.
• Ensuring safe working conditions.
• Working with on call teams when problems are escalated.
• Training maintenance and operative staff where appropriate.

Qualifications, Knowledge and Skills Required:

• At least 3 years’ experience with installation and configuration of Server / Network infrastructure for Virtualised Systems solutions in the biotechnology or pharmaceutical industry is required.
• Emerson DeltaV Infrastructure experience desirable
• Proficiency with Cisco IOS and experience administering large cisco networks.
• Experience with HyperV Clusters and DeltaV Virtual Studio
• Experience with Dell Multi-host blade systems
• Experience administering and maintaining DeltaV Systems.
• Experience in the preparation of method statements, safe plans of action and work permits
• Understanding of documentation such as Hardware Design, Network design, FAT and SAT documentation
• Experience with Active Directory infrastructure and administration
• Experience with Microsoft Windows Sever 2008, 2012 and 2016
• Experience with Thin Client Software solutions
• Knowledge of cGMP particularly as it applies to biologics manufacturing and automated systems.
• Ability to keep work pace and meet deadlines. Good organising and planning skills.
• Strong communication skills. Problem solver with a focus on achievement of overall project goals
• Proven success working well in a team environment with flexibility to react to changing business needs
• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilising technical, project management, and business expertise
• Ability to work independently and remotely with minimum direct supervision
• Ensuring compliance with practices, policies, procedures, legal requirements and goals of project sponsors and approved methodologies, develop supporting documentation and monitor budget tracking/ timeliness/ scheduled resources

Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level:

• Passion: We pursue excellence to help patients prevail.
• Innovation: We embrace new ideas.
• Accountability: We own our outcomes and the outcomes of others.
• Speed: We act with urgency and agility.

Why should you apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days,  life assurance, on-site gym and gain-sharing bonus.

Join us and make a difference

At Bristol-Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference.

We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb (BMS) is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. BMS also has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.

BMS Global Quality External Manufacturing is looking to recruit a permanent Qualified Person, responsible for the batch certification of finished drug product.

Key responsibilities will include, but not limited to:        

• The QP must personally ensure that the following operational responsibilities are fulfilled prior to certification of a batch for release to market or for export:
  • Certification is permitted under the terms of the MIA (Manufacturing and Importation Authorisation).
  • Any additional duties and requirements of national legislation are complied with.
  • Certification is recorded in a register or equivalent document.

• All activities associated with manufacture and testing of the medicinal product have been conducted in accordance with the principles and guidelines of GMP.
• Familiarisation with conditions of the MIA and ensuring that the conditions are observed in day to day operations.
• All sites of manufacture, analysis and certification are compliant with the terms of the MA for the intended territory.
• All manufacturing activities and testing activities are consistent with those described in the MA (Marketing Authorisation).
• The source and specifications of starting materials and packaging materials used in the batch are compliant with the MA. Supplier quality management systems are in place that ensure only materials of the required quality have been supplied.
• For medicinal products that fall within the scope of Directive 2001/83/EC, as amended, or Directive 2001/82/EC, the active substances have been manufactured in accordance with GMP and, where required, distributed in accordance with Good Distribution Practice (GDP) for Active Substances.
• The importation of active substances used in the manufacture of medicinal products for human use should comply with the requirements of Article 46(b) of Directive 2001/83/EC, as amended.
• For medicinal products that fall within the scope of Directive 2001/83/EC, as amended, the excipients have been manufactured in accordance with the ascertained GMP referred to in Article 46 (f) of that Directive.
• When relevant, the TSE (Transmissible Spongiform Encephalopathy) status of all materials used in batch manufacture is compliant with the terms of the MA.
• All records are complete and endorsed by appropriate personnel. All required in-process controls and checks have been made.
• All manufacturing and testing processes remain in the validated state. Personnel are trained and qualified as appropriate.
• Finished product quality control (QC) test data complies with the Finished Product Specification described in the MA, or where authorised, the Real Time Release Testing programme.
• Any regulatory post-marketing commitments relating to manufacture or testing of the product have been addressed. On-going stability data continues to support certification.
• The impact of any change to product manufacturing or testing has been evaluated and any additional checks and tests are complete.
• All investigations pertaining to the batch being certified (including out of specification and out of trend investigations) have been completed to a sufficient level to support certification.
• Any on-going complaints, investigations or recalls do not negate the conditions for certification of the batch in question.
• The self-inspection programme is active and current.
• The appropriate arrangements for distribution and shipment are in place.
• In the case of medicinal products for human use intended to be placed on the market in the Union, the safety features referred to in Article 54(o) of Directive 2001/83/EC, as amended, have been affixed to the packaging, where appropriate.
• Informing the Competent Authority in advance (in writing) of any proposed changes which will affect an authorization.
• Familiarization with the individual product regulatory dossiers
• Coordination of the Quality Operations team to support batch certification activities.
• That the requirements of Good Manufacturing Practice are observed during manufacturing operations, including but not limited to: oversight of compliance and quality activities, Quality Risk Management, internal and supplier auditing, inspection management, records management, and change control.
• That the manufacturing and control procedures are not changed unless these have been approved by the relevant Competent Authority. Conversely, the QP must be aware of any amendments to the Marketing Authorization and must ensure that these are implemented on the agreed dates.
• Collaboration with MS&T and other functional areas to support new product introductions.
• Approval of change controls, deviations (including out of specification and out of trend investigations), customer complaints and annual product quality reviews as required.
• Ensure quality agreements are in place to support the batch certification process
• Participate in regulatory and corporate audits as required.
• Participation in the site self-inspection programme by conducting audits of site functions as required.
• Actively support the BMS Fact Finding (FF)and Product Review Committee (PRC) processes for investigations.
• Participation in the product recall process and Competent Authority notification process.
• Undergo continuous professional development including self-study, site visits, internal and external training courses to keep abreast of current trends in manufacturing technology, GMP and regulatory affairs.
• In the event of a serious quality defect, the QP should ensure that the Competent Authority is involved in the decision making process to perform a recall.
• Where it is necessary to recall a batch(es), the QP should ensure that the recall is comprehensive and expeditious. The QP should ensure that the reason for the recall is fully investigated and that appropriate corrective and preventative actions are put in place.

Qualifications and Experience required:

• The successful candidate will have 5 years in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
• Candidate must be qualified to act as Qualified Person on the Manufacturing/Importation Authorisation, and will preferably have experience QP certifying sterile and oral solid dosage product presentations.
• Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
• In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
• Direct experience interacting with Health Authorities and managing Health Authority inspections, specifically FDA and/or EMA.
• Direct experience in interacting with external manufacturers and managing quality at external manufacturing sites.
• Ability to assess the right balance between business targets and scientific and quality decisions.
• Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers.
• Strong negotiation, communication and presentation skills across all levels both internal and external to BMS.
• Strong analytical and problem solving skills.
• Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level. The BMS Behaviours are: Passion, Innovation, Accountability and Speed.

Why should you apply:

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family health insurance, 23.5 days annual leave plus 3 Company days,  life assurance and gain-sharing bonus.

Join us and make a difference

At Bristol-Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference.

We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol Myers Squibb (BMS) has one of the richest biopharmaceutical pipelines in the industry. We discover, develop, and manufacture lifesaving and life altering drugs in cancer, hepatitis C, heart disease, and other therapeutic areas. BMS also has one of the most reliable supply networks and our clinical operations program is among the best and busiest anywhere. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and the transformation work underway will enable us to continue to lead our peer group.

BMS Global Quality External Manufacturing is seeking to recruit a permanent Associate Director, Qualified Person Lead, who will perform Certification of batches of finished product to be released to the EU/EEA and ROW markets, and lead a team of Qualified Persons who will also perform such certification.

Key responsibilities will include, but not limited to:

• The QP will personally ensure that the following operational responsibilities are fulfilled prior to certification of a batch for release to market or for export:
  • Certification is permitted under the terms of the MIA (Manufacturing and Importation Authorisation).
  • Any additional duties and requirements of national legislation are complied with.
  • Certification is recorded in a register or equivalent document.
• All activities associated with manufacture and testing of the medicinal product have been conducted in accordance with the principles and guidelines of GMP.
• Familiarisation with conditions of the MIA and ensuring that the conditions are observed in day to day operations.
• All sites of manufacture, analysis and certification are compliant with the terms of the MA for the intended territory.
• All manufacturing activities and testing activities are consistent with those described in the MA (Marketing Authorisation).
• The source and specifications of starting materials and packaging materials used in the batch are compliant with the MA. Supplier quality management systems are in place that ensure only materials of the required quality have been supplied.
• For medicinal products that fall within the scope of Directive 2001/83/EC, as amended, or Directive 2001/82/EC, the active substances have been manufactured in accordance with GMP and, where required, distributed in accordance with Good Distribution Practice (GDP) for Active Substances.
• The importation of active substances used in the manufacture of medicinal products for human use should comply with the requirements of Article 46(b) of Directive 2001/83/EC, as amended.
• For medicinal products that fall within the scope of Directive 2001/83/EC, as amended, the excipients have been manufactured in accordance with the ascertained GMP referred to in Article 46 (f) of that Directive.
• When relevant, the TSE (Transmissible Spongiform Encephalopathy) status of all materials used in batch manufacture is compliant with the terms of the MA.
• All records are complete and endorsed by appropriate personnel. All required in-process controls and checks have been made.
• All manufacturing and testing processes remain in the validated state. Personnel are trained and qualified as appropriate.
• Finished product quality control (QC) test data complies with the Finished Product Specification described in the MA, or where authorised, the Real Time Release Testing programme.
• Any regulatory post-marketing commitments relating to manufacture or testing of the product have been addressed. On-going stability data continues to support certification.
• The impact of any change to product manufacturing or testing has been evaluated and any additional checks and tests are complete.
• All investigations pertaining to the batch being certified (including out of specification and out of trend investigations) have been completed to a sufficient level to support certification.
• Any on-going complaints, investigations or recalls do not negate the conditions for certification of the batch in question.
• The self-inspection programme is active and current.
• The appropriate arrangements for distribution and shipment ​are in place.
• In the case of medicinal products for human use intended to be placed on the market in the Union, the safety features referred to in Article 54(o) of Directive 2001/83/EC, as amended, have been affixed to the packaging, where appropriate.
• Informing the Competent Authority in advance (in writing) of any proposed changes which will affect an authorization.
• Familiarization with the individual product regulatory dossiers.
• Coordination of the Quality Operations team to support batch certification activities.
• That the requirements of Good Manufacturing Practice are observed during manufacturing operations, including but not limited to: oversight of compliance and quality activities, Quality Risk Management, internal and supplier auditing, inspection management, records management, and change control.
• That the manufacturing and control procedures are not changed unless these have been approved by the relevant Competent Authority. Conversely, the QP must be aware of any amendments to the Marketing Authorization and must ensure that these are implemented on the agreed dates.
• Collaboration with MS&T and other functional areas to support new product introductions.
• Approval of change controls, deviations (including out of specification and out of trend investigations), customer complaints and annual product quality reviews as required. 
• Ensure quality agreements are in place to support the batch certification process.
• Participate in regulatory and corporate audits as required.
• Participation in the site self-inspection programme by conducting audits of site functions as required.
• Actively support the BMS Fact Finding (FF) and Product Review Committee (PRC) processes for investigations.
• Participation in the product recall process and Competent Authority notification process.
• Undergo continuous professional development including self-study, site visits, internal and external training courses to keep abreast of current trends in manufacturing technology, GMP and regulatory affairs.
• In the event of a serious quality defect, the QP should ensure that the Competent Authority is involved in the decision making process to perform a recall.
• Where it is necessary to recall a batch(es), the QP should ensure that the recall is comprehensive and expeditious. The QP should ensure that the reason for the recall is fully investigated and that appropriate corrective and preventative actions are put in place. 

Qualifications and Experience required:

• You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family health insurance, 23.5 days annual leave plus 3 Company days,  life assurance and gain-sharing bonus.

• Core competencies include leadership and communication skills. Proficient communicator and collaborator at a variety of levels. Proven success working well in a team environment with flexibility to react to changing business needs. Demonstrated problem solving and project management skills.

• Educated to a degree level in science, engineering or related discipline with a minimum of 8 years experience in the biopharmaceutical/ pharmaceutical industry

• Eligible to act as a QP in accordance with the EU Guide to Good Manufacturing Practice.

• Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level.

  The BMS Behaviours are: Passion, Innovation, Accountability and Speed.

Why should you apply:

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family health insurance, 23.5 days annual leave plus 3 Company days,  life assurance and gain-sharing bonus.

Join us and make a difference

At Bristol-Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference.

We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

POSITION SUMMARY:

The primary role of the Dispensary Technician is to perform functions relevant to Dispensary and Dispensary staging activities in manufacturing facility.  Core functions include material selection from the warehouse, dispensing, material returns and raw material sampling.  Related activities include supply upkeep, cleaning, environmental monitoring, and bulk chemical transfers.  All operations are to be performed in a safe and compliant manner.

Duties/Responsibilities:

• Maintain clean working environment, including material handling equipment.
• Material transfers to and from the Dispensary and Operations.
• Maintain accurate and detailed logs-cleaning, scale, dispensing, etc.
• Perform environmental monitoring for the ISO environments, including LIMS.
• Maintain gowning qualifications for respective areas.
• Follow daily schedule and Batch Records to precisely weigh and dispense raw materials to Operations.
• Follow weekly Crate Parts schedule to issue non-BOM materials to Operations.
• CIP (manual or automatic) dispensing supplies.
• Pump bulk Sodium Hydroxide and Phosphoric Acid to the buildings day tanks.
• Sample raw materials.
• Serve as training designee as directed when training and qualifications are appropriate.
• Batch, filter, and aliquot solutions as required.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

• A well rounded warehousing, materials handling, buffer/media make up or sampling background is preferred.
• Committed to Safety and GMP compliance.
• Individual needs to have ability to motivate and act compliantly with shifting priorities.
• Strong understanding of safety hazards and best practices for safe working behaviors.
• Shift work, overtime, and weekends may be required.
• Detailed computer skills required: Microsoft Office applications.
• Must be highly organized.

Education/Experience/ Licenses/Certifications:

The successful candidate will have a BS/BA degree in a science related or a minimum of 1 years equivalent experience.

Physical Demands:

This position is part of the hands-on dispensing and manufacturing process in a medium-scale manufacturing facility, with classified areas that require appropriate personal protective equipment (PPE).  Physical demands may include lifting (not to exceed 50 lbs), frequent bending/stooping, twisting, crouching/squatting, reaching, repetitive use of arms/hand/wrists, and grasping.  This position spends the majority of time standing in an ISO 8 manufacturing environment weighing and issuing raw materials.  Operators may be required to drive a fork lift, operate a WAVE and other powered equipment.

Work Environment:

The position is located in a medium-scale manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE).  Personnel are required to wear scrubs, and additional and multiple levels of gowning as required by area classification, to include clean room area for sampling and dispensing operations (ISO 8 and ISO 5).  This role may require contact with hazardous materials such as caustic, acids and steam.  At times, the work environment can be subject to extreme heat and noise.  The position is based indoors and is a team-based position that may require rotating shift work, weekends, holidays, and overtime.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.  One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support.  Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

The Group Leader, Biologics Analytical Methods is accountable for establishing analytical control strategy of major quality attributes by developing robust analytical methods for biotherapeutic drug candidates in the portfolio of Bristol-Myers Squibb spanning early and late stage clinical programs. This position directly reports to the Head of Methods & Analytical Development within Biologics Development organization.

Bristol-Myers Squibb is the industry leader in immuno-oncology and other innovative therapies with life-saving medicines such as Opdivo®, Yervoy®, Empliciti®, Eliquis®, and a rich clinical portfolio of diverse modalities including monoclonal antibody, fusion protein, gene therapy, and combination regimes. The candidate will have opportunity to work on a variety of biologic compounds across various therapeutic modalities, and actively partner with various biologics development & commercialization groups across sites in New Jersey, New York, Massachusetts, and globally.

Responsibilities:

Directly accountable for:

• Assessing and establishing analytical control strategy for major quality attributes such as protein aggregates, fragments, charge variants, chemical modifications, and other product-related substances/impurities;
• Development, validation, and transfer of chromatographic, electrophoretic, and mass spectrometric (MS) methods targeted for in-process, release and stability for early and late stage biologics development programs;
• Understanding performance of the methods - both scientific as well as robustness;
• Direct supervision of scientific staff, and maintaining/initiating strong collaboration with partner groups;
• Strong focus on advancing our capabilities in attribute sciences including new technology development;
• Prepare and/or review documents in support of CMC regulatory filings and addressing queries from health authorities

Key Competencies:

• Ph.D. in analytical sciences, biotechnology, pharmaceutical sciences, biochemistry, or equivalent field, with a minimum of 8 years (or MS with minimum 13 yrs) of relevant experience in biotech/biopharma.

• Experience in biologics development including analytical sciences and protein sciences

• People management experience; strong interpersonal and communication skills.

• Deep knowledge and experience in applying chromatographic, electrophoretic, and MS methods to therapeutic proteins. Such as SE-HPLC/UPLC, RP-LC, IEX, HIC, CGE/CE-SDS, iCIEF, HILIC, 2D-LC, LC-MS etc.

• Proven technical leader with direct experience in analytical method development, validation, and forced degradation

• Must have a clear understanding of global regulatory filing requirements for biologics.

• Desired: Experience interacting directly with CROs and Health Authorities (FDA, EMEA etc).

• Desired: Experience in biologics process development, characterization, CQA assessment, and multi-attribute techniques.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Position Description and Responsibilities

This individual is a member of cross-functional development teams and will support Biostatistics TA Head of Immunoscience to provide expert and independent statistical leadership in support of the development of Tyk2 in IBD indications (such as Crohn’s disease and ulcerative colitis), including guidance on statistical methods, appropriate study design, data analytical approaches and interpretation of results.

• Support the Biostatistics TA Head to ensure execution of development strategy of Tyk2 with respect to development of indication-specific methodology, study designs, data collection, reporting and interpretation as well as regulatory and HTA interactions.
• Develops an effective partnership with the Biostatistics Asset Leads (BAL) to ensure the team’s ability to execute with quality in agreed to timelines. Provide statistical guidance/oversight to BAL at the strategic partner.
• Demonstrate a high degree of knowledge regarding the asset including knowledge of the underlying disease(s) and potential mechanism(s) of action, as well as current treatment landscape, up-to-date scientific literature and issues related to regulatory submission history of related products.  Utilize data mining techniques to explore historical data to enhance development strategy for Tyk2 in IBD.
• Collaborate effectively with colleagues from multiple drug development functions by driving statistical thinking, and proper data interpretation. 
• Influence the broader organization with respect to innovation in clinical study design

Position Requirements

Ph.D. (or equivalent) in Statistics or related field. Seven years or more in Pharmaceutical/R&D or other related experience, including supporting regulatory filings in multiple regions (e.g. US, EU, Japan).  Experience in planning for & participating in regulatory meetings, (e.g. US FDA).  Expertise in general & cutting edge statistical/clinical trials methodology & ability to apply to relevant clinical development framework.  Demonstrated ability in solving complex statistical problems. Excellent verbal and written communications skills. Ability to work successfully in cross-functional teams leading to successful global regulatory filings and approvals. Strong communication/presentation skills with ability to tailor the message to the key stakeholder for effective impact and influence. Ability to be flexible and adapt quickly to the changing needs of the organization. Ability to organize multiple work assignments and establish priorities. Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs.  Experience in development of compounds in IBD preferred.