Director, QC Microbiology, CTDO Quality Control

Bristol Myers Squibb•Summit, NJ

3d•$184,550 - $223,634•Onsite

About The Position

The Director, QC Microbiology is responsible for all operational aspects of the Quality Control Microbiology organization at the CAR T facility in support of stability programs, testing of raw materials, in-process controls, and final product samples, reading environment monitoring plates from routine and dynamic sampling from manufacturing area and supporting QC micro investigations.

Requirements

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.
Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.
Ability to collaborate cross functionally to drive operational and quality excellence.
Advanced organizational and time management skills.
Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
Advanced teamwork and facilitation skills.
Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
Requires strategic thinking and ability to work independently.
Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.
Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.
Ability to interpret and author general, technical, and complex business documents.
Advanced knowledge and implementation of data integrity principles.
Ability to represent the department in regulatory inspections.
Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.
Proficiency in MS Office applications.
Ability to develop and manage a departmental budget.
Ability to manage headcounts.
Ability to lead projects to completion.
Ability to design microbiology laboratory space and drive lean lab initiatives.
Knowledgeable about micro assays including endotoxin, mycoplasma, rapid sterility method, automated EM plate reads
Bachelor’s degree required, preferable in Chemistry, Microbiology, or related science.
10 years of relevant work experience required. Higher education may be counted towards work experience.
Leadership experience with direct reports required.

Nice To Haves

Advanced degree preferred.

Responsibilities

Manages all activities related to the Quality Control Microbiology department including: Stability testing, Raw material, in-process, and final product testing, Environmental Monitoring, Method validations/maintenance, Metrics/data analysis, Investigations
Manages and develops direct reports including: Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs.
Ensuring employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports.
Performs other tasks as assigned.

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays each year
160 hours of paid vacation annually for new hires
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day