Associate Director
4 weeks ago
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
**Position**: ASL Associate Director, Analytical Strategy & Lifecycle Group Lead
**Location**: Cruiserath / Devens
**Qualifications & Experience**:
- A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 10, 13 or 15 years of biologics experience within analytical CMC / relevant field, respectively.
- Biological License Applications (BLA), Rest of World (ROW) & Post Approval Submissions (PAS) filing preparation & review
- Health Authority Information Requests (IRs)
- Follow Up Measures (FUMs) and Post Marketing Commitments (PMCs)
- Method lifecycle and associated Change Control’s
- Extensive experience in leading and managing analytically related complex Health Authority communications and providing Health Authority strategies with a high probability of technical and regulatory success.
- Requires highly advanced knowledge of the relevant principles and concepts of analytical CMC (JOS / Analytical Procedures / Method Validation/ analytical comparability/reference standard strategy) and associated GMP’s.
- Proven track record in independently authoring complex technical CMC documents (Justification of Specification / Analytical Comparability Risk Assessments, Protocols & Reports / Method Summaries, Method validation gap assessments etc.).
- Extensive industry experience in independently writing formal reports/documents, technical presentations, articles for publication, and scientific publications or patents.
- 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.
- Ensures achievement of business objectives and metrics while routinely leading projects or teams successfully through difficult challenges.
- In-depth knowledge of common analytical techniques used in the bio-pharmaceutical industry such as iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS etc., method qualification, method development, and method transfer.
- In-depth knowledge of FDA and international regulatory guidelines and standards as well as extensive experience with supporting Health Authority inspections.
**Key Responsibilities**:
- Recruits, manages, develops, and mentors a high-performing team of ASL scientists and/or Analytical Product Leads responsible for the delivery of analytical CMC strategy with a vision of maintaining industry scientific standards.
- Accountability for strategy and execution of analytical activities (method validation strategy/specification setting/reference standard strategy/ analytical comparability) required to advance late-stage programs and manage the analytical lifecycle of commercial programs.
- Provide strategic leadership on behalf of analytical during all Biological License Applications (BLA), Rest of World (ROW) & Post Approval Submissions (PAS) filing review and works with analytical development in supporting the responses to Follow Up Measures (FUMs) and Post Marketing Commitments (PMCs).
- This person is accountable for leading the execution of the analytical control strategy and associated Book of Work for multiple commercial brand (s).
- 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.
- Provide analytical leadership for their respective brands during Health Authority inspections.
- Provide strong technical analytical leadership to Quality Control and Manufacturing teams during complex method troubleshooting/investigations/tech transfers/method validations.
- Responsible for leading and managing the analytical development and support of the analytical quality control strategies during late-stage and post-approval (commercialization) phases.
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your
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