Associate Director, Analytical Quality & Compliance
The Associate Director in Analytical Quality & Compliance will focus on the oversight of the Biologics Specification Committee (BSC), serving the BMS biologics community in the development of robust specification documentation from preclinical through the end of commercial lifecycle. This leadership role requires the candidate to manage a matrix team of subject matter experts while driving continuous improvement of the BSC business processes and associated specification processes throughout the BMS biologics organization. The Associate Director will also work to document best practices, procedures, and guidance in an appropriate manner in support of the BSC and other quality efforts in the department.
- Chair the Biologics Specification Committee (BSC) to facilitate the technical evaluation of specification documents (Justification of Specification) by the BSC in support of the release and stability testing of drug substances, drug products, and placebos within the BMS biologics portfolio from preclinical through the end of commercial lifecycle for the Integrated Development Teams (IDTs) and the Technical Product Teams (TPTs)
- Lead the strategic evolution of the Biologics Specification Committee by improving business processes and evaluating the technical/scientific aspects of specifications
- Lead and/or participate in opportunities to build, define and improve associated specification processes that interface with the BSC business or scientific process
- Develop and document templates, standards and procedures to support the robust development of a specification document in an appropriate technical and/or standard operating procedure format
- Document or revise existing documents governing the BSC in directives, SOPs or technical documents to support operations and strategy
- Communicate with ATLs/APQLs/IDTs/TPTs/BSC members and other stakeholders on an individual and collective basis for the purpose of knowledge sharing and continuous improvement
- Evaluate the performance of BSC individuals as a matrix leader of the BSC. Provide feedback, coaching and mentoring to BSC members in addition to performance information to their supervisors.
- MS in a life science field, Ph.D. preferred
- Minimum of 10 years of experience in biologics development (process development, formulation development, stability, analytics), preferably having a strong background in the analytical analysis of biopharmaceuticals.
- Experience in authoring/reviewing of CMC submissions is highly desired.
- Broad knowledge and understanding of the overall biologics development and commercialization process as applied to the integration of process development, formulation and stability, and analytics to develop a specification
- Demonstrated leadership capability to achieve success when working and leading virtual teams in a matrix organization
- Demonstrated ability to operate independently and have appropriate judgement to make or facilitate decisions, particularly as related to the justification of specifications
- Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the biopharmaceutical landscape for the development of specifications
- Demonstrated excellence in developing key stakeholder buy-in.
- Demonstrated ability to drive performance and achieve results
- Demonstrated ability to identify and develop synergies, across functional and business organizational lines that support BSC strategic objectives.
- Superior communication, relationship management, consensus building, negotiation, analytical and problem-solving skills