Associate Director - Global Validation and Technical Services
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
We are looking for an Associate Director level candidate to join our Global Validation and Technical Services team in Global Manufacturing Science and Technology (GMS&T).
The successful candidate will lead efforts related to build out of Bristol Myers Squibb's first internal vector facility for clinical and commercial operations. Responsibilities include facility and equipment validation and GMP readiness for successful transfer of clinical and commercial vector processes into the new facility in compliance with our internal cell therapy global standards. Candidate will interface with the ECQ/contractors, vector MS&T, vector validation, Vector Process Development and broader BMS network to leverage expertise and knowledge across modalities. The candidate will also contribute to any significant facility and equipment validation issues, troubleshooting efforts and keep teams abreast of project advancement, rapid and best in class execution, and challenges/opportunities. The leader will ensure cross-departmental collaboration to enable facility fit, development of process documentation, personnel training, change control ownership, and technical support of validation and quality related deliverables, as well as development and support of PPQ strategies and commercial manufacturing. This position reports to the Senior Director of Validation & Technical Services in Summit, NJ.
- The initial focus area for this position is to manage the strategy and planning for the buildout of BMS' internal viral vector facility capable of supporting clinical and commercial manufacturing.
- Lead facility and equipment qualification efforts to ensure facility readiness for operation
- Interface with Vector Process Development and Vector MS&T teams to understand equipment needs for the processes, manage capital engineering projects, ensure timely equipment procurement and completion of SAT, FAT and IOQ/PQ activities
- Support process and technology transfers and change management, and batch record generation for vector process intermediates for cell therapy drug product manufacturing
- Ensure compliance with cell therapy global standards while identifying opportunities for improvements, make formal recommendations, and drive improvements to completion
- Manage identification and implementation of new technologies and procedures from Development into Manufacturing
- Leverage and maintain strong relationships with internal and external partners
Specific Knowledge, Skills, Abilities, etc:
- The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
- Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, manufacturing support and technology transfer.
- Proven track record of managing validation projects
- Demonstrated leadership skills, and the ability to interact with and lead diverse groups and teams are essential.
- Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team-based environment are required
- Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment required
- Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment required
- Prior experience facilitating/participating in Risk Assessments preferred
- Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing: Minimum of a B.Sc/B.Eng with 14+ years or a M.Sc/M.Eng degree with 10+ years or Ph.D. degree with 8+ of experience
- Preference given to candidates with experience writing regulatory submissions and participating in interactions with health authorities
- Knowledge of cellular immunology a plus
- Experience with cGMP, ICH guidelines, PPQ (process validation), control strategy development, and working within a Quality organization
- Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
- Experience working in a self-driven, performance/results oriented, fast paced matrix environment
- Position requires repetitive use of hands and wrist (computer work)
- Occasional bending, twisting and stooping to allow for gowning into classified environment required
- Position is primarily office based with occasional work in a classified GMP manufacturing environment
- Position is a team & project-based position that will require occasional shift work, weekends, and holidays
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.