Description
A Scientist in the analytical CMC bio group plays a supporting role for Biologic product lifecycle activities. This position focuses on providing support to commercial and late stage products with a specific focus on analytical CMC strategy, enabling regulatory filings, provide technical partnership for quality control laboratories around the world, support managing the lifecycle of specifications (methods and acceptance criteria), and authoring responses to health authority questions on commercial products.
The scientist will operate in a matrix team responsible for preparation of licensure applications, rest of world filings, follow-up measures, post-approval commitments and prior approval submissions. Through a level of independence, the scientist will ensure the support of analytical methods and analytical change control across the BMS network, for third party manufacturing and our partners at outside testing labs. The scientist is responsible for data gathering, interpretation and presentation to support decision making, and product analytical strategies
Roles and Responsibilities
This position will be located at the Bristol-Myers Squibb site in Cruiserath, Ireland / Devens, MA. The scientist will collaborate across BMS sites with analytical development, global quality product leads, technical project teams, and regulatory leads to generate and execute the commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of life cycle regulatory filings.
- Create and maintain effective partnerships with stakeholders from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success, as necessary.
- Manage and coordinate analytical activities for late-stage and commercial programs.
- Effectively support team matrix for analytical topics during all BLAs, ROW & PAS filing review and work with analytical development in supporting the responses to FUMs and PMCs.
- Participates on the implementation of effective control strategy, analytical method and specification change control as needed throughout the BMS network, third party manufacturing and outside testing labs.
- Serve as technical point of contact for project activities, including technical evaluations of methods and data.
- Provide technical support and guidance to QC teams during method troubleshooting / investigations / tech transfers / method validations.
Qualifications, Knowledge and Skills
- Working knowledge of analytical methodologies used for the development and commercialization of biologics.
- Understanding of product characterization and strategies to establish process and product knowledge.
- Working knowledge of the relevant principles and concepts of analytical CMC (JOS / Analytical Procedures / Method Validation etc.) and associated GMP’s.
- Proficient in the execution of some of the key analytical CMC activities (BLAs/ ROW & PAS filing preparation & review, supporting responses to FUM’s and PMC’s / method lifecycle / electronic Change Control’s).
- Demonstrates ability to analyze and interpret data to draw appropriate conclusions, identify problems/gaps, and recommend potential next steps or solutions to ensure good scientific, compliance and regulatory outcomes.
- Proven track record in writing formal reports/documents, technical presentations, articles for publication and scientific publications or patents.
- Proficient in the preparation / protocols, methods/processes, experimental and/or authoring plans and/or templates as appropriate.
- Possess a strong sense of time management and the ability to meet tight deadlines.
Education/Experience/ Licenses/Certifications
- A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 2 of biologics experience within analytical CMC / relevant field, respectively.
