Implements and owns Data Lake solutions for BMS Commercial.

Key Responsibilities

Plan

• Collaborate with Business and IT Plan functions to define business requirements, define project timelines and budget, develop acceptance criteria, testing, training and change management plans
• Develop and communicate Commercial data lake program roadmap

Build

• Design, develop and implement data lake solutions focused on Commercial
• Work with Solution Architects to design solution
• Own solution architecture for applicable Commercial data lake solutions

Run

• Provide IT operational support of all Commercial data platforms
• Determine the hyper care and support model by partnering with engineering team & business partners
• Manage the outsourced IT support for the Commercial data lake platform

Architecture

• Partner with Enterprise Architecture and Data Architecture teams to develop and execute data architectural strategies for the Commercial data capabilities
• Define and clarify functional requirements & develop logical data models in conjunction with Data Architecture team
• Identify opportunities for platform simplification and partner with engineering team to implement

Data Management

• Collaborate with the Enterprise Data Governance team to define and refine the data security, data quality, governance and policies for all on-boarded data assets 
• Partner with the Enterprise Analytic Data Management team to define and refine the data rules for all data assets

Qualifications

• 4 year bachelor’s degree required in Computer Science, MIS or related field; MS or related advanced degree is a plus
• 10-12+ years overall work experience in Information Technology with 3 in data related disciplines
• 3 years domain experience in Commercial and comfort with both the business and technical processes to answer any questions
• Technical expertise in one or more data warehousing, data integration and/or data preparation technologies with an ability to be hands-on
• Strong communication and relationship building skills to establish trust and rapport with the business teams
• Ability to clearly articulate the Commercial data capabilities roadmap, status of requests and issues both with IT Business Partner Organizations and core functional teams
• Proven experience in leading data solution and data integration projects
• Good influence and facilitation skills
• Strong project management skills
• Good understanding of Data Management principles
• Experience in driving adoption of process changes
• Proficiency at demonstrating the Core BMS Behaviors

The Immuno-Oncology group in Redwood City is seeking a highly motivated and talented individual to join our Discovery Research team. The ideal candidate will enjoy working in a team environment to advance basic research programs as well as drug development. In this role, the individual will be responsible for coordinating and executing experimental plans that will contribute to the understanding of mechanism of action of immune regulation by therapeutic targets. Communication skills, problem solving, and a desire to perform high quality work are necessary. Strong organizational skills will be highly preferred. This position will also offer an opportunity to expand both knowledge and skills.

Responsibilities:

• Providing expertise in basic Immunology and stromal biology and applying that to understanding anti-tumor immune responses
• Developing novel assays for the characterization of the immune system integrating the current scientific literature into research practice
• Designing and executing experiments in both in vitro human systems and in vivo/ex vivo mouse models
• Analyzing and presenting scientific results to internal and external scientists
• Working in a collaborative team environment

Qualifications:

• A PhD in immunology or a related field, and 0-4 years of relevant experience in industry and/or academic immuno-oncology or immunology research with a minimum of 3 years flow cytometry experience.
• Eligible to work with BSL2 pathogens, including Listeria monocytogenes

Skills and Experience:

• A sophisticated understanding of and expertise in the isolation, characterization, and development of functional assays of human and mouse T cells is essential.
• An understanding of the methodologies, reagents, instrumentation and software used for flow cytometry based key experimental techniques is essential.
• Experience with in vivo and ex vivo tumor and tissue analysis in mouse models of T cell-driven immune responses is preferred.
• Experience with systems for assessing stroma-immune-tumor interplay is desirable.
• Ability to work safely in a BSL2 environment is desirable.
• General molecular biology experience involving isolation, manipulation, and characterization of DNA, RNA and proteins is helpful.
• Demonstrated independent ability to skillfully design, execute, and analyze experiments.
• Excellent attention to detail, organization, and record keeping.
• Exceptional written and verbal communication skills.
• Proven ability to collaborate in a team environment.

Do you have strong leadership skills, the ability to compliantly execute, and have a positive, can-do winning attitude? If you answered yes, and you bring a passion for helping patients and a desire to excel, we want to talk with you.

We are currently looking for a specialty biologic Immunoscience Account Manager in the Gulf Coast area who will have responsibility for selling Nulojix and Orencia IV, for appropriate patients. Your focus will include the transplant team at key transplant centers as well as community-based rheumatologists.

Even more specifically, you will excel in:

Understanding and applying knowledge of health care industry trends, applicable laws and regulations, market conditions, and the managed health care environment.

Developing and implementing territory plans that properly identify and prioritize activities to accomplish business plan goals.

Demonstrating clear and thorough understanding of disease states, BMS products and relevant competitor products, including mechanisms of action, indications, safety, and efficacy.

Collaborating with extended matrix team on identifying opportunities and developing appropriate strategies and tactics.

Building and maintaining strong professional relationships with physicians in hospitals, private practice, medical group practices, office staffs and others in the patient care continuum.

Fostering team effectiveness and accomplishment of shared goals by sharing knowledge, experience, and information.

Driving market share growth and maximizing sales performance within the indicated use and for the approved patients.

The successful candidate must possess each of the following:

Bachelors degree or equivalent with minimum of 5 years pharmaceutical sales/medical experience.

Infusion/injectable, buy and bill, and Medicare Part B reimbursement experience.

Hospital/Institutional experience with specialty pharmaceutical or biotech products.

Proven track record in sales, sales/territory planning & tactical execution.

Ability to understand and communicate complex disease and product concepts, possess a deep understanding of hospital/institution-based customer needs, and clearly articulate messages to address those needs.

Strong written and oral communications, account analysis and planning, teamwork/team effectiveness, working in a matrix team environment, and communicating shared objectives.

A high degree of passion, speed, and accountability while working in a rapidly changing environment.

Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network.

Demonstrated ability to analyze, develop and execute business plans.

Extensive travel is required in some territories.

As this position requires operation of a Company-provided vehicle, offers of employment are contingent upon the candidate meeting the requirements of “Qualified Driver,” as determined by the Company in its sole discretion, including but not limited to the following: 1) at least 21 years of age; 2) a driver’s license in good standing issued by your state of residence; and, 3) a driving risk level deemed acceptable by the Company.

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.