Scientific Associate Director - Cell Therapy Materials Science

Bristol Myers Squibb•Devens, MA

5d•$173,440 - $231,184

About The Position

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. 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. The Cell Therapy Materials Science team is responsible for management of end-to-end raw materials, buffers, reagents, media, and single-use systems (SUS) used to support commercial CAR-T therapies. This individual contributor role will be responsible for management of raw material suppliers, deviations, change notifications and troubleshooting/ investigations related to materials used in drug product manufacturing. This role will also serve as the Material Health Committee lead, responsible for driving the coordination and resolution of emerging materials issues and trends. Responsibilities will include, but are not limited to, the following: Provide technical support on RM/SUS to the drug product manufacturing team. Strong focus on critical raw material issue resolution. Lead the technical support pillar of Materials Science by facilitating Material Health Committee meetings to intake new issues and continuous improvements, monitor KPIs, align functional area ownership, and coordinate resolution. Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and robustness of existing RM/SUS. Lead/support projects for qualification of new or alternate sourcing efforts for RM/SUS. Build strategy for lifecycle changes and raw material robustness. Collaborate with Manufacturing, Process Development, Analytical R&D, Quality Operations, MSAT network to ensure raw material oversight. Support internal and external manufacturing site(s) on investigations related to RM/SUS. Provide necessary technical analysis to support impact assessments for investigations and change control (internal and supplier change notification). Facilitate the development of appropriate mitigations and corrective actions. Support supplier quality assurance (SQA) on vendor management including change controls, audits, deviations, and Quality Risk Management (QRM) programs. Lead/support technical diligence and audits to RM/SUS supplier sites with cross-functional teams. Support other members of the team with deviations, change control, and project support for RM/SUS for late stage clinical/commercial CT/vector. Author the RM/SUS section of the filing for new regulatory submissions. Author responses for Information Requests (IR) from regulatory bodies. This role reports into the Director – CT Materials Science, Cell Therapy Technical Operations (CTTO).

Requirements

BS/MS/PhD with 12 or more years development / manufacturing technologies for biologics, vaccines, or cell therapy. A combination or related experiences/degrees may also be acceptable.
A minimum of 2 years raw material experience is required (single use systems and/or media/ buffer/ reagents).
Experience with Quality Management System (example: Deviation, CAPA, Change Management).
Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
Knowledge of GMP manufacturing practices and documentation requirements.
Ability to assess risk and develop contingency plans for process risks.
Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
Detail oriented with excellent verbal and written communication skills.
Strong interpersonal and leadership skills to work with teams in different functions and organizations.
Understanding of regulatory requirements for raw materials used in biomanufacturing.

Nice To Haves

Knowledge of the manufacturing process for CT/LVV/Vaccines/Biologics.
Lean Manufacturing experience is desired.
Experience working with RM/SUS suppliers for biopharmaceutical, cell therapy, or vector manufacturing, including collaborative engagement on investigations, technical diligence, and strategic initiatives.
Experience working with multiple suppliers across a range of categories (filters, resins, reagents, media, single use components, excipients and other specialized critical raw materials).
Knowledge on life cycle management (LCM) of raw materials (both liquid and single use system).
Knowledge of managing Extractables and Leachables (E&L) protocols/studies.
Experience with a variety of regulatory agencies and compendial requirements is strongly preferred.
Contributes to industry consortia (e.g., BPOG) to drive establishment and improvement of industry best practices and standards for raw material development and management.
Established track record of success, sound technical qualifications and knowledge in process transfers.
Cell therapy development or related field, aseptic manufacturing, and validation experience a plus.
Strategic thinker with excellent problem solving and conflict resolution skills.
Experience managing a technical team is required.
Ability to foster a strong team-first environment with the ability to lead multiple projects.
Self-motivated, excellent time management, organizational, written, and oral communication skills.

Responsibilities

Provide technical support on RM/SUS to the drug product manufacturing team.
Strong focus on critical raw material issue resolution.
Lead the technical support pillar of Materials Science by facilitating Material Health Committee meetings to intake new issues and continuous improvements, monitor KPIs, align functional area ownership, and coordinate resolution.
Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and robustness of existing RM/SUS.
Lead/support projects for qualification of new or alternate sourcing efforts for RM/SUS.
Build strategy for lifecycle changes and raw material robustness.
Collaborate with Manufacturing, Process Development, Analytical R&D, Quality Operations, MSAT network to ensure raw material oversight.
Support internal and external manufacturing site(s) on investigations related to RM/SUS.
Provide necessary technical analysis to support impact assessments for investigations and change control (internal and supplier change notification).
Facilitate the development of appropriate mitigations and corrective actions.
Support supplier quality assurance (SQA) on vendor management including change controls, audits, deviations, and Quality Risk Management (QRM) programs.
Lead/support technical diligence and audits to RM/SUS supplier sites with cross-functional teams.
Support other members of the team with deviations, change control, and project support for RM/SUS for late stage clinical/commercial CT/vector.
Author the RM/SUS section of the filing for new regulatory submissions.
Author responses for Information Requests (IR) from regulatory bodies.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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