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Associate Director
5 months ago
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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.
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. Read more:
Position: ASL Associate Director, Analytical Strategy & Lifecycle Group Lead
Location: Cruiserath / Devens
The Associate Director of Analytical Strategy & Lifecycle will lead a team of experienced scientists, both direct and matrix reports, to deliver and implement analytical control strategies for late-stage and commercial biological products within the Global Quality organization. This leadership role will provide comprehensive analytical oversight for multiple biological brands within the broader Biologics Analytical Methods & Strategy group under the Global Quality & Analytical Sciences (GQCAS) pillar. Key responsibilities include ownership of the analytical CMC strategy, which encompasses strategic oversight of drug substance and drug product analytical methods, specifications, reference standards, and comparability studies. In addition, the ASL Associate Director will be accountable for enabling regulatory filings (analytical related), defining strategies for follow-up measures and prior approval submissions, and strategizing responses to health authority queries.
The ASL Associate Director will also be responsible for implementing strategic initiatives that will develop and integrate best practices across brands, Analytical Sciences, and GPS. These initiatives will include, leading, and strategizing control strategy improvements providing robust Health Authority Strategies with a high probability of technical and regulatory success across the portfolio of biological brands.
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. Requires extensive in-depth knowledge in the application and execution of key analytical CMC activities in the commercial environment including but not limited to: 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 Controls 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 GMPs. 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. If you come across a role that intrigues you but doesnt perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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 role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
