Bristol-Myers Squibb 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.

Join us and make a 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.

ROLE IMPERATIVES

As a Development Team Lead in Earl Development, this leader is accountable for: (i) creating a vision, and defining the strategy and development plan for each exploratory asset within their portfolio, (ii) developing a set of objective criteria against which each asset advancing through the Early Development pipeline will be evaluated to enable robust and rapid decision making; and (iii) ensuring that only high quality and differentiated assets enter the full development pipeline. The DP Leader will oversee a multi-disciplinary team typically responsible for multiple development assets within assigned therapeutic area from later stage Discovery through transition to Full Development.

Strategy & Execution
• Uses an understanding of disease biology in assigned therapeutic area, the early-stage drug development process (particularly cross-functional connectivity), and relevant late-stage challenges (e.g., trends in disease area, regulatory, and market access) to create a vision, then design and execute effective exploratory development programs in support of the overall R&D portfolio goals.
• Effectively engages cross company expertise and utilizes advisory groups and governance bodies (e.g., TPC, Development LTs, PSC) to define, revise and champion asset development strategies and implementation plans.
• Continually analyzes progress, engages in critical thinking, and asserts strong problem-solving toward delivering key data and interpretation essential for robust and rapid decision making on assigned projects.
• Delivers high quality assets to Full Development which have the potential for a competitive profile to address the unmet medical needs of patients and to provide favorable shareholder return.
• Ensures the process and output of the team meets established program standards (per PD&C Process expectations, within budget, on schedule, compliant, etc.), while also looking for opportunities to streamline development and enable continuous improvements without compromising quality.
• Engages senior leaders and functional area stakeholders to ensure alignment of program strategy and operational plans with functional area capabilities, and clearly communicates program risks, implications of changes in the competitive landscape and progress toward key milestones.

Leadership & Matrix Alignment
• Forward looking, objective matrix leader with demonstrated ability to frame issues, ask the right clarifying questions, and rationalize decisions in a cost disciplined manner, with an enterprise view.
• Experience/judgment to efficiently integrate information from team members/key advisors to facilitate making rapid and objective decisions.
• Sets goals and objectives for asset development; ensures aligned functional and individual objectives (for self and team members) across the BMS matrix to accomplish the asset development plan.
• Oversees relevant sub-teams and ensures clear goals and performance standards are in place, provides feedback and coaching, appropriately delegates responsibilities, and holds sub-team leaders accountable for key deliverables.
• Builds, proactively manages, and professionally develops a high performing team with diverse perspectives
• Builds productive peer to peer relationships with functional heads of all groups to ensure optimal functional area cooperation and resource support needed for optimal delivery on goals and overall portfolio priorities.

DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE
• MD , PhD, DVM, PharmD, MBA, or equivalent advanced degree of relevance
• Experienced drug developer with 10+ years’ experience in the drug development process, with particular in-depth know how and experience in the exploratory development space.
• Deep understanding of the role of basic biology, pharmaceutical optimization, and translational medicine in exploratory development
• Strong understanding of relevant regulatory health authority expectations and regulations for drug development, with a focus on exploratory development but with an understanding of implications toward full development
• Working knowledge of all functional areas of exploratory development, including chemistry/biochemistry, biology, toxicology, CMC, translational medicine, early clinical development, etc.
• Demonstrated scientific acumen and mechanistic understanding of disease biology within assigned therapeutic areas

• Ability to create a clear purpose, global vision, strategies and key priorities for competing successfully in the evolving pharmaceutical and health care industry
• Demonstrated ability to execute Development Plans which have global perspective and focus on product differentiation, including opportunities for data driven acceleration
• Demonstrated ability to objectively assess complex but relatively sparse data sets and make informed decisions and take action in the face of uncertainty.
• Experience in successfully managing and leading high performing, cross-functional matrix teams or complex multi-functional organizations
• Ability to effectively and seamlessly multitask across multiple exploratory development assets.
• Demonstrated ability to successfully and effectively cooperate, collaborate and work across functional boundaries

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.

Bristol-Myers Squibb 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.

Join us and make a 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 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.

Bristol-Myers Squibb 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.

Join us and make a 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.

Summary:

The Technical Lead is the shift's technical expert in the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs).

Responsibilities:

- Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations. – striving for right first time through adherence of GMP activities.

- Change control identifiers – works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation Investigation identifiers – initiate investigation following alignment with QA floor Communicate and resolve operational variances.

- Serve as the “acting” Shift Supervisor/Manager in absence of Shift Supervisor/Manager – Coordinate, direct and oversee work execution and manage personnel related issues.

- Executes real time process monitoring – including equipment and key process parameters review and work with Shift Supervisor/Manager to drive required decisions.

- Drive implementation of process enhancement and new technology in partnership with Project lead and Manufacturing Technology team.

- Participate in performance review discussion

- Leads complex investigations on floor – drives technical issues in working with cross functional team members.

- Support real time process reports review and resolve open issues. 

- Trend issues and strives to right first time.

- Technical trainer for the shift – provides consistent training to the staff

- Execute and drive continuous improvements.

- Support Tech transfer team through active participation in ensuring that new process  can fit and executes in sustainable manner

- Being resource to support routine investigations and CAPAs– author, review, approval, in case of excess investigation beyond planned capacity.

- Assigned area owner – drive facility upkeeps  

- Adheres to Good Manufacturing Practices and standard operating procedures.

- Weighs and checks raw materials. 

- Assembles, cleans and sterilizes process equipment, monitors processes.

- Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.

- Operates and trains others all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipments or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.)

- Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).

- Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions and that training is completed on time.

- Assists with the coordination and implementation of special projects such as validation or complex investigations.

- May provide scheduling and work assignment guidance to peers. 

- Modifies group work plan, schedule or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary, regularly provides training and operational guidance to other staff. 

- Advises Shift Supervisor/Manager on improvements which may optimize work processes and informs of work issues requiring management action

Knowledge/Skill:

• B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
• A minimum of 5+ year’s process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
• Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP) and strong technical and operational knowledge of either upstream and/or downstream unit operation is essential.
• Demonstrated experience in solving complex technical issues in biologics manufacturing.
• Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
• Previous work experience where attention to detail and personal accountability were critical to success
• Demonstrates good interpersonal skills, is attentive and approachable.
• Maintains a professional and productive relationship with area management and co-workers.
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

Excited to grow your career?

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.

This position is part of the IT Service Management team and plays a key role in overseeing the Change & Release process, a vital foundational component of the IT Service Management practice at Bristol-Myers Squibb. The Change and Release Management process is a critical control process to minimize risk and disruption to IT services when a change is implemented in production.  The Enterprise Change Manager role is suitable for someone who is process oriented with an eye for details, comfortable working in a dynamic environment, able to manage competing demands and can work independently.

Expectations of the role include the following:

• Chair the Change Advisory Board (CAB) to perform impact analysis in order to minimize risk and disruption to the changes made production environment.
• Assess change readiness with feedback from the impacted stakeholders; Ensure that quality of the change conforms to the IT change policy
• Schedule the Change Advisory Board meetings.
  • Identify opportunities and deploy efficiencies within the Change & Release process
  • Work closely with Service Providers to ensure compliance to the change process
  • Monitor and Govern the health of the Change process for adherence, performance & quality  through Reporting and Analytics
  • Monitor  Emergency Change violations
  • Respond promptly to audit questions and requirements
  • Apply skills as a seasoned, experienced professional with a full understanding of industry practices and established policies and procedures to perform trend analysis and guide Change & Release operations. 
  • Perform UAT testing during upgrades or Enhancements (Build & Execute testing scripts )
  • Provide consulting services within the team and to other BMS departments in recommending corrective and preventive actions
  • Lead process interactions between Change & Release  and other processes/teams, including Quality Management
  • Author & curate Job Aids and other documentation.
  • Conduct  Annual Change & Release Training for new & existing users to ensure adherence to the process
  • Support Change & Release  Process Owner as needed
  • Provide input into Service Management Office, present findings and make recommendations as needed

Qualifications

• Excellent interpersonal and communication skills; ability to form strong relationships within a matrix organization.
• Good understanding of service management principles thinking in a service context, and defining outcomes-based delivery.
• Must be detail oriented, analytical, and demonstrate ability to work in a dynamic environment. Must be self-directed with proven ability to make mature decisions supported by thorough data analysis.
• Manage competing priorities
• General understanding of IT services including Application development, Network infrastructure & Hosting
• Project management skills a plus

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.

Bristol-Myers Squibb 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.

Join us and make a 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 Purpose
The Celgene BCF Lead, represents the Business Controls Function (BCF) as the internal controls lead that will advise and support the Celgene operations to manage financial, operational and fraud risk. This position reports directly to the Executive Director, Head of Global Business Controls (the Executive Director) and will be a member of the BCF Leadership Team.  The individual is a key contributor to the BCF, based in Summit, NJ with travel as needed to Princeton, New Jersey and directly supervise one employee.  This position will focus on maintaining the strength and sustainability of the control environment as the Celgene processes and controls are integrated with that of BMS.  The individual selected for this position will help implement best practices, remain abreast of developments, serve as partner to the business process owners, work closely with other BCF team members and incorporate concerns from these sources into the Company’s financial risk management and compliance program.  

Duties & Responsibilities

Governance
•    Regular engagement with management in key business processes and functions to proactively identify and mitigate financial, operational and fraud risk
•    Lead implementation of overall operating standards, framework and special projects to achieve the BCF organization strategic objectives 
•    Provide interpretations of corporate policies and procedures to business process owners (BPOs)
•    Liaise directly with the Company’s internal/external auditors to ensure their activities are efficient and effective and needs are met, while minimizing burden on business process owners (e.g., business process walkthroughs, level of reliance on the Company’s financial controls compliance program, etc.)
 
Internal Control Maintenance & Enhancements
•    Evaluate adequacy and effectiveness of proposed risk mitigation program and control enhancements

•    Serve as a consultant prior to implementing any recommended changes to globally designed controls, processes or procedures in the Celgene operations
•    Monitor the Company’s third party controls testing team, who perform a significant portion of control testing on behalf of BMS
•    Provide assistance in analysis of internal control deficiencies of significance, including analysis of pervasiveness and financial magnitude, and drafting of related whitepapers

Sarbanes-Oxley (SOX) & Quarterly Sub-Certification Activities
•    Evaluate all Celgene out-of-period financial statement adjustments, control failures and Global Internal Audit & Assurance (GIA) observations for potential SOX deficiency reporting
•    Work with the BCF leadership team to make determinations as to the pervasiveness and financial magnitude of control deficiencies, and to design effective and efficient remediation plans
•    Work with business process owners to identify and evaluate the Company’s most significant changes in the internal control environment.  This task includes evaluating changes to systems, processes and personnel that have an impact on BMS financial, operational, and fraud risk
•    Follow-up on all financial control deficiency and fraud risk remediation measures, whether arising from Sarbanes-Oxley testing, the quarterly close process, internal audit observations, the BCF risk assessment, anti-bribery corruption and fraud monitoring, etc.  Report quarterly and more frequently as necessary, to senior BCF and operational leadership on the status thereof through formal, quarterly meetings
•    Participate in annual walk-throughs with BPOs and external auditor

Audit Support
•    Assist and support as necessary local operations and Finance with internal and external audits (e.g., responding to inquiries, providing explanations regarding controls, policy/procedure, end-to-end process, reviewing and consulting on findings/observations)
•    Determine the appropriateness of any GIA-recommended remediation activities, in particular in response to a qualified or adverse internal audit report opinion, or in response to recommendations that suggest significant system or process change
•    Follow-up to ensure that BPOs promptly remediate audit observations within the GPS, R&D and Medical functions

Education/Experience
•    Bachelor’s degree in accounting or related financial field
•    Certified Public Accountant or equivalent strongly desired
•    Knowledge of the Sarbanes-Oxley Act, including sections 302 and 404, the COSO Framework, and Public Company Accounting Oversight Board promulgations
•    Deep understanding of risk across all key business/financial cycles
•    Proficient in US GAAP accounting provisions, accounting principles, audit and disclosure requirements of financial statements
•    10 years minimum of professional experience in accounting, audit, and/or internal control. Big 4 public accounting / consulting experience desirable
•    Process and control documentation experience desirable
•    Experience with process enhancement and systems implementation initiatives and/or working in a transformational environment

Functional/Technical
•    Understanding of internal controls, SOX regulations, as well as operational and financial business processes
•    Ability to effectively represent the BCF to senior leadership
•    Ability to manage multiple projects and competing priorities, while working independently or with a team, with speed and accountability
•    Business partner attitude and ability to collaborate and influence leaders
•    Ability to work with a range of technically and culturally diverse people
•    Strong written and verbal communication to facilitate relationship building with peers and senior management.  Comfort presenting to BCF leadership.
•    Works well in an ever-evolving environment of complexity and uncertainty
•    Ability to execute solutions in a confident and successful manner

Developmental Value
•    Develop subject matter expertise in all Sarbanes-Oxley matters, including the COSO framework, sections 302 and 404 of the Sarbanes-Oxley Act (SOX), and key risks for the Company’s financial statement business cycles
•    Opportunity to contribute to the enhancement of an already best in class financial risk management program
•    Opportunity to be part of a professional and high performing team of over 90 diverse professionals, that is continually evolving and reacting to the key, top-of-mind risks facing senior management and an integral contributor to the Company’s overall enterprise risk management program 

•    Position will provide exposure to all types of risk, including financial, strategic, operational, fraud, compliance, and other areas

•    Develop the ability to impact and influence within the Company to deliver superior business results and protect shareholders
•    Opportunity to contribute to the execution of the BCF’s long-term strategy and growth of the department
 

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

ENGINEER / SCIENTIST – MS&T DOWNSTREAM

The Engineer / Scientist – Manufacturing Sciences & Technology Downstream serves as a technical lead and subject matter expert in the areas of purification and primary recovery, including mixing, chromatography, viral clearance, ultrafiltration/diafiltration, filtration, formulation, and primary recovery unit operations, to support late-stage and commercial manufacturing of biologics drug substance.

The successful candidate will be a key contributor to a highly technical, diverse, and collaborative team of scientists and engineers. MS&T scientists and engineers contribute to cross-functional teams to meet highly visible business objectives. Deliverables include manufacturing process support, characterization of next-generation processes, process technology transfer and validation, submission of regulatory filings, and technical leadership during interactions with health authorities.

This position offers the opportunity to interface with Manufacturing, Manufacturing Support, Process Development, Quality Assurance, Analytical, and Global Regulatory Sciences groups. 

Responsibilities:

• Lead the design and execution of experiments in purification and primary recovery unit operations for the investigation and resolution of process deviations in the Large-Scale Cell Culture and Single-Use Facilities at the Devens, MA site through the effective design of bench and pilot scale-downs studies and the evaluation of data from manufacturing lots.
• Technical support of drug substance handling and cryogenics operations at Devens may be required.
• This position is based at the Devens site and may provide technical support to additional sites within the internal or external manufacturing network.
• Provide technical expertise for root-cause analysis, corrective and preventative actions (CAPA), process improvements, and scale-down model development.
• Author and review technical documentation, including validation protocols and reports and multilayered impact assessments.
• Lead process characterization and initial scale-up for intensified processes and integrated analytical technologies in collaboration with Process Development, Analytical, and Operations groups.
• Contribute to regulatory filings and inspection campaign readiness activities.
• Provide process subject matter expertise, representing the Devens site, during inspections and other interactions with regulatory agencies.
• Demonstrate a strong knowledge of cGMP compliance, BMS corporate, site, and regulatory agency requirements and procedures.

Qualifications:

• PhD or MSc in Chemical Engineering or related field with 0–2 or 4–6 years, respectively, of relevant industrial and/or academic experience. 
• Knowledge of protein purification, protein stability, and demonstrated experimental skills for laboratory work are required.
• Experience with AKTA purification and ultrafiltration/diafiltration operations is helpful.
• Critical qualities include a high degree of curiosity and initiative, good verbal and written communication skills, strong scientific skills and attention to detail, and the ability to work independently and in a team environment.
• Interpersonal and facilitation skills are necessary to interface with and influence across levels of the organization.

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.

Bristol-Myers Squibb 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.

Join us and make a 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 Responsibilities
Several bullets, each describing a distinct and primary responsibility of the role; avoid step-by-step instructions on duties and assignments; executive roles are typically 5-8 bullet points; junior, administrative and tactical-type roles, list duties and specific responsibilities
• Describe major accountabilities or primary duties
• Include measurable performance indicators
• Include time-sensitive information (e.g. weekly, monthly, annual deliverables)
• Include decision-making responsibilities and people-management responsibilities (if applicable)
• Avoid generic comments such as “works well with others”, etc.
Indicate if travel may be required: intermittent or extensive.

Desired Experience
Required:
Plain un-bolded text; use up to 5 bullet points; focus on prerequisite skills, competencies and years of appropriate experience that would typically prepare a candidate for the position; reference professional, technical and industry (broadly) ; avoid specifying pharmaceutical experience, unless it is a vital prerequisite; don’t use internal jargon or acronyms (without first spelling them out); use full name for the company - not “BMS”

Ideal Candidates Would Also Have:
Nice to have skills; plain un-bolded text; use up to 3 bullet points; focus on expanded skills, avoid specific pharmaceutical experience if at all possible unless Pharma and/or biotech experience supports becoming operational much sooner

Other Qualifications:
Specific education, years’ professional or specialized experience, and/or prior disease area expertise; do not overstate or limit the scope of academic / professional qualifications; college degree(s) and major required to apply for this role; if there is a specific degree major/majors or professional qualifications that are advantageous, but not critical, place it here as “preferred”; encourage applicants with non-traditional work history; this includes consideration of US military service towards industry experience.

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

Summary:

Responsible for leading the Parenteral manufacturing process assuring compliance with applicable policies, regulations, and procedures. Meets budget objectives and productivity or process / line defects targets. Drive area projects to completion. Keep work pace and plan work schedules, set priorities with urgency and meet deadlines within a complex, rapidly changing environment. The incumbent must comply with Corporate and HR Policies, FDA, GMP, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Major Duties and Responsibilities:

1.    Oversees resources availability (material, equipment, personnel – regular and lease workers) necessary to meet and comply with timely production plan.
2.    Verifies adherence to procedures and controls and provides corrective feedback during operations by frequent monitoring of production activities
3.    Performs systematic walkthroughs of operation floors. .
4.    Establishes corrective actions plan to eliminate process deviations and documentation errors.
5.    Supports efforts to release lots on hold and conducts thorough reviews of investigation reports.
6.    Supports Annual Requalification Program by assuring on time execution of requalification activities
7.    Supports Environmental Monitoring Program by assuring on time samples/data collection and delivery
8.    Defines job skill requirement for the manufacturing positions which includes back up operators for critical positions and supports the training program design assuring adherence to training plan including employee certification and re-certification program.
9.    Prepares and/or approves necessary SOP’s and forms to be in full compliance with cGMP’s and reflect manufacturing processes.
10.    Complies with Company Environmental, Health, and Safety goals programs and objectives.
11.    Monitors scrap factor, equipment downtime, and labor utilization on a regular basis for effective and efficient production plan Execution.
12.    Identifies opportunities to improve process performance and / or safety requirements. Supports Continuous Improvement initiatives in the daily operation activities.
13.    Generates and approve changes as per the established Change Control procedure.
14.    Assists in preparing manufacturing budget, and establishes effective cost control programs to meet budget targets and objectives per company strategic plan.
15.    Prepares on time performance reviews and manage disciplinary actions as needed. Monitor attendance trends enforcing applicable Company policies and procedures.
16.     Performs as back up of the area Manager as required. 
17.    Supports Maintenance Program by assuring on time execution of applicable preventive and corrective maintenance plans.
This is intended to be a general job description and should not be construed as all-inclusive.

Knowledge/Skill:
•    Bachelor Degree in Science, Administration, or Engineering 
•    Five (5) years experience in Compounding, Sterilization, Aseptic Filling and/or Lyophilization processes, and product transfer validation  in a Pharmaceutical manufacturing environment, 
•    Three (3) years of solid supervisory experience, or leading multidisciplinary teams  ( disciplinary actions, performance appraisals, development of succession plans, etc).
•    Ability to facilitate continuous innovation initiatives, foster team building and simplify processes.
•    Ability to maintain good employee relations and to handle grievances and complaints.
•    Self-starter with strong leadership characteristics, analytical, administrative and people skills.  
•    Ability to communicate and work effectively in a team oriented environment.
•    Knowledge of cGMPs, safety and environmental regulations, human resources and labor laws.
•    Personal computer skills, knowledge in Excel, Word, PowerPoint, Internet.
•    Fully bilingual oral and written (Spanish/English). Technical writing skills.
•    Sense of urgency and business needs.
•    Capability to use protective gowning 
•    Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary.
 

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

Bristol Myers Squibb External Manufacturing is looking for a permanent Manufacturing Science and Technology Senior Specialist (Drug Product) to provide technical support and leadership to the External Manufacturing Organisation and Contract Manufacturing Organisations (CMOs). In addition to this, the Manufacturing Science and Technology Senior Specialist will ensure the transfer of robust manufacturing processes and robust process performance during commercial manufacture by use of continuous process verification and OPEX.

Key Responsibilities:

• Provision of ongoing technical support and oversight for a portfolio of Drug Products, ensuring compliance and security of supply - metrics review, investigation close-out, change control review, annual reviews and continuous improvement.
• Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required.
• Represent Manufacturing Science and Technology on multifunctional project teams.

cGMP Responsibilities/Critical Tasks

• Documentation (Transfer documentation, Appraisals, technical memos and reports, Regulatory filing etc.).
• Trackwise deviation investigations.
• Technical support for Change Control system.
• Training Gap Analysis and Planning.

Manage Finance

• Work with assigned CMOs to identify and agree potential process optimisations.
• Reduce costs associated with existing processes.
• Participate and lead on teams for cost reduction projects.

Key Requirements:

• Expert Strong knowledge in Drug Product - Oral Solid Dosage, Semi-solids, Liquids, Sterile/Aseptic products manufacturing.
• A 3rd level degree in science or a related field.
• 5+ years relevant industrial experience.
• Good understanding of engineering, analytical and regulatory (cGMP, filing, EHS) aspects of DP manufacture
• Demonstrated project management and technical leadership capability.
• Demonstrated capability in the use of standard tools for root cause analysis. Ability to close-out investigations and issues at CMOs.
• Understanding of statistical process analysis and control methods.  Ability to use statistical software to analyse process related data to determine process capability or for troubleshooting purposes.
• Proven experience of technology transfer process.
• Excellent verbal, written communications and presentations skills, to include the ability to document complex study plans and scientific reports; notifications to line management regarding critical issues related to product manufacturing and process validation where appropriate.
• Strong communication and negotiation skills as well as the ability to translate technical issues into business impact and relevant solutions.
• Ability to work on own and as part of a team and to drive issues to resolution.
• Proven record in pharmaceutical technology -  pharmaceutical process scale-up, technical transfer andor  manufacturing support/activities.

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 health insurance, 23.5 days annual leave plus 3 Company days,  life assurance and gain-sharing bonus.

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.

Bristol-Myers Squibb 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.

Join us and make a 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.

Aufgabengebiet:

·         Initiate and advance external partnerships with key academic research centers and as appropriate, pan-European scientific societies, and cooperative groups in his/her region or territory. In this capacity, the Associate Director/Director will also be responsible for developing, managing, and evolving the strategic medical plan for the partnerships and operationalizing the governance for each partnership

·         Build and maintain trusted relationships with leadership at partner centers (including Thought Leaders, Institutional executives, and department chairs) and serve as the primary contact for BMS at those institutions 

·         Advance the BMS scientific strategy by collaborating extensively with stakeholders across multiple departments, including Research & Early Development, Translational Research, Medical, Clinical Operations, Commercial, Public Affairs, Legal and Business Development and by matching partners’ capabilities with BMS’ strategic needs

·         Develop and implement program level projects covering a specific area across all sites

·         Advance BMS’ organizational knowledge of the unique capabilities of the partner and report impactful and actionable insights from interactions.

·         Act as the link between the Worldwide teams, country teams, and the sites to ensure that the mutual commitments of each partnership are consistently met 

·         Advance the Global Strategic Collaborations Program through identification of areas for collaboration, continuous improvement for the program and new opportunities

·         Maintain oversight of all contractual aspects of his/her partnerships as required (planning, milestones, budget forecasts)

Anforderungsprofil:

·         Advanced degree in area relevant to Life Sciences preferred (ie. Pharm.D., PhD, MD, MS)

·         Significant experience in the pharmaceutical industry and/or significant experience with collaborative projects, thought leader engagement or partnerships (public and/or private) 

·         Able to innovate, analyze and solve problems with attention to detail

·         Understanding of drug development across the continuum from development to commercialization (oncology / immunosciences preferred)

·         Strong interpersonal, public communication and negotiation skills

·         Proven track record of managing complex interactions and discussions

·         Strong project management skills and substantive track record in working effectively with cross-functional teams including remote interactions

·         Experience working in diverse international environments

·         Experience working with scientific leaders and external healthcare stakeholders

·         Track record of effective budget management

·         Fluent in English and German

·         Ability and willingness to travel nationally and internationally

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.