Scientific Associate Director – Cell Therapy Materials Science

Role Overview

• 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.

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.

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.