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Bristol-Meyers Squibb, Co.

Manager, Stability Scientist (R1555393-en-us)





Devens, Massachusetts, United States

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.

Reporting to the Associate Director, Global Biologics Stability (GBS). The Stability Scientist is responsible for activities related to the global stability studies. Activities include protocol authoring, LIMS study approval, stability data evaluation and trending, authoring stability reports and stability sections of CMC regulatory filings. The stability scientist supports the Global Biologics Stability program for BMS and Third Party Manufacturers (TPM). The stability Scientist will also assist with Stability Assessments, Study Generation and Sample Management. Activities are performed in accordance with cGMP and Company SOPs and as requested by management.

Role Responsibilities:

  • Execute stability program activities for the commercial biologic products. Author master stability protocols, stability study protocols. Evaluate stability study LIMS build for accuracy. Critically review stability documents for consistency and quality.

  • Work in collaboration with Global Regulatory Sciences, CMC teams and technical experts to author CMC stability sections of initial and post approval HA submissions.

  • Author site APQR/APR and end to-end APQR/APR and present the data at internal meetings.

  • Author ad-hoc stability filings and submissions. Respond to HA stability questions. Complete and close all stability studies.

  • Point person for global rollout of observations that may impact stability programs and develop strategies to close gaps/mitigation.

  • Approve, identify, write and revise SOPs. Assist with development of company directives.

  • Data entry and verification in the electronic laboratory information management system (LIMS).

  • Support Health Authority inspections and internal inspections

  • Act, escalate, identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly and promptly to management.

  • Works according to cGMP requirements and HA expectations.

Role Requirements:

  • Minimum of 2 years (PhD)/ 6-8 years (MS)/ 8-10 years (BS) relevant cGMP experience in biopharma at BMS or other company

  • Knowledge and understanding of ICH Guidelines (Q1A, Q5C), US/EU/ROW stability requirements, and industry best practices. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a biologics manufacturing facility

  • Excellent technical writing skills. Experience authoring CMC filing sections

  • Ability to work collaboratively in a team matrix environment

  • Experience with evaluating and interpreting stability data using statistics and statistics software

  • Applied knowledge and good understanding of analytical and/ or Microbiology techniques

  • Experience in Operational Excellence, with proven record of accomplishment in continuous improvement

  • Prior experience with stability programs and demonstrated expertise in Biologics or Protein Therapeutic molecules

  • Use computer software/programs: Microsoft Office applications, SAP, LIMS, Trackwise, JMP, etc.

  • Front room FDA/Inspectional experience is preferred.

  • Experience working on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors


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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.