Bristol Myers Squibb Company

Associate Director - CMC-QA, Product Development Quality

Location
Summit West, NJ, United States
Posted
Sep 02, 2020
Ref
R1528308
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

This position develops Quality strategies for the CMC activities (drug substance, API, drug product, and analytics) for compounds in Product Development (small molecules and biologics). The emphasis of the position will be on biologics compounds but may expand to small molecules. The incumbent will be responsible for multiple projects.

Division

Clinical Quality

Location

To be based in one of our the development sites (likely New Brunswick/Summit)

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
  • Thorough knowledge of the Pharmaceutical Development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval. Knowledge of bulk biologic drug substance (monoclonal antibody, bispecific, etc.) and parenteral (cold chain liquid/lyophilized form) drug product is required. Knowledge of devices for biologics (e.g., combination product) would be considered an advantage.
  • Recognized as a CMC Biologics expert with an ability to introduce best practices into the quality management systems.
  • Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).
  • Well-versed in relevant CMC area, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.
  • Excellent investigational and QA problem-solving skills. Analytical mindset, with an ability to assess new situations to define and implement the appropriate QA action plan.
  • Ability to work independently, yet effectively in a team environment.
  • Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
  • Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).
  • Other proven competencies such as strategic thinker, influencer, and a negotiator are required.
  • Continuous improvement mindset and operational excellence qualified


DUTIES AND RESPONSIBILITIES

  • Member of CMC Development Teams providing Quality (QA) input from pre-clinical to late-phase development (until start of PPQ) to BLA/NDA filing. Partners with technical SMEs to develop and approve the CMC strategy for new drug candidates.
  • Responsible for change control management through the product lifecycle to include impact assessments, tracking, and implementation. Also, as appropriate, responsible Quality member for oversight of all key Quality System deliverables associated with the drug development candidate including proactive Initiatives, Deviations, Investigations, CAPAs, and Complaints.
  • Work with CMC Teams to conduct risk assessments, as required, for all aspects of the drug development process. Responsible for communicating Quality risks within the Quality organization.
    • Collaborate with Regulatory to track/own Quality input for ongoing regulatory filings and updates to Health Authorities (e.g. IND/IMPD/BLA/NDA) including specifications, shelf life extensions, country specific trial approvals, etc.
    • Performs other tasks as assigned (e.g., final Quality reviewer/approver for GMP documentation).


EDUCATION AND EXPERIENCE
  • Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar Scientific field.
  • Ten plus years of hands on biologics/sterile experience within a development/operations facility (manufacturing and/or analytical).
  • Prior experience in Quality is preferred.
  • An equivalent combination of education and experience may be substituted


WORKING CONDITIONS (US Only)

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.