Associate Director, Qc Microbiology

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BMS is hiring for an Associate Director, QC Microbiology to join QC Microbiology, CAR T team located in Summit, NJ. The Associate Director is responsible for all microbiological contamination control processes/procedures at the S12 manufacturing site. The Associate Director will work closely with QA, Facilities, Manufacturing Operations, QC, and MS&T to ensure practices and policies are in place to identify, assess, and prevent potential microbial contamination issues within the facility (including laboratories), as well as during the manufacturing and testing processes. The Associate Director also plays a critical role in supporting facility design/modifications, cleaning and sanitization, the aseptic process validation (APV) program, operator qualification/requalification, introduction and validation of new technologies/methods, method transfers, microbiology-related investigations, and the gowning certification/recertification program.

Responsibilities:

Manage the overall microbial contamination control strategy including, but not limited to:

• Evaluation and implementation of new technologies/methods
• APV strategy
• EMPQ strategy
• Establishing and implementing appropriate training programs in collaboration with training leads
• Site microbial contamination risk assessment
• Participation in external forums to remain current with industry trends to ensure procedures, policies, and practices remain current
• Harmonization of policies, practices, and procedures across CAR T sites globally
• Ownership of relevant internal and external inspection responses/action items related to contamination control issues
• Site microbial contamination control SOP/Policy

Play a critical role in supporting overall facility operations including:

• Aseptic process validation
• Manufacturing support
• Training
• Investigations
• Gowning certification
• Facility design and modifications
• Cleaning and sanitization program
• Inspections and audits
• Operator qualification

Knowledge, Skills, and Abilities:

• Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.
• Advanced teamwork and facilitation skills.
• Advanced organizational and time management skills.
• Ability to collaborate cross-functionally to drive operational and quality excellence.
• Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Management (including Assessments and FMEA).
• Advanced knowledge and understanding of industrial/pharmaceutical microbiology, aseptic manufacturing, environmental control, and monitoring, and compendial and rapid microbiology methods.
• Strategic thinking and ability to work independently.
• Advanced knowledge and implementation of data integrity principles.
• Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.
• Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.
• Ability to act as an SME during internal/regulatory inspections.
• Advanced influencing, negotiating, and personal interaction skills.
• Advanced knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
• Ability to interpret and author technical documents.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Proficiency in MS Office applications.

Basic Qualifications:

• Bachelor’s degree, preferably in Microbiology or related science.
• Demonstrated experience with Environment Monitoring and Sterility Assurance
• Regulatory agency interaction experience
• Minimum of 10 years of Microbiology work experience within a GMP environment

Preferred Qualifications:

• Advanced degree preferred.
• Experience with Facility Design Impact

Working Conditions (US Only):

• The incumbent (or designee) will be expected to be on call to support manufacturing or laboratory issues involving potential microbial excursions or questions during shift operations.
• The incumbent may be required to gown for entry into the Aseptic Core and other supporting areas on a routine basis.
• The incumbent will be required to work in office and laboratory environments.
• Occasional travel may be required.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Some other duties and responsibilities are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 [email protected]. 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.