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Associate Director

4 months ago

Devens, United States Bristol-Myers Squibb Full time

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. 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:

careers.bms.com/working-with-us

. 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.

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 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 .

If you come across a role that intrigues you but doesn’t 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 Careers With 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

adastaffingsupport@bms.com

. Visit

careers.bms.com/

eeo

-accessibility

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.

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