9 дней назад
Supervisor, Quality Control (Microbiology)
107 185 - 138 710$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Supervisor, Quality Control (Microbiology) (QC Microbiology and GMP): Overseeing microbiological testing, environmental and utilities monitoring, investigations, documentation, and product release support in a regulated cell therapy manufacturing environment with an accent on compliance, contamination control, and laboratory operations. Focus on supervising QC Microbiology personnel, analyzing monitoring trends, leading OOS and deviation investigations, and implementing effective CAPAs.
Location: Frederick, Maryland, United States; onsite laboratory role
Salary: $107,185–$138,710 per year, plus potential annual bonus, stock-based incentives, paid time off, and benefits.
Company
is a biopharmaceutical company developing CAR T-cell and TCR-engineered cell therapies for cancer treatment.
What you will do
- Oversee daily QC Microbiology laboratory operations and microbiological testing supporting manufacturing and product release.
- Lead environmental monitoring and utilities monitoring programs, including data trending, reporting, and compliance updates.
- Supervise QC Microbiology personnel, conduct performance evaluations, provide coaching, and maintain staff qualification programs.
- Lead or support investigations into environmental and utilities excursions, OOS results, and microbiological deviations.
- Develop, review, and approve SOPs, validation and qualification protocols, reports, and controlled quality documentation.
- Support audits and inspections while collaborating with Manufacturing, Quality Assurance, Validation, Facilities, and other functions.
Requirements
- Bachelor’s degree in Microbiology, Biology, Biochemistry, Life Sciences, or a related scientific discipline.
- At least five years of QC Microbiology experience in a pharmaceutical, biotechnology, cell therapy, or other GMP-regulated environment.
- Previous supervisory or laboratory personnel leadership experience.
- Strong experience with environmental monitoring, utilities monitoring, aseptic processing, gowning qualification, OOS, deviation, CAPA investigations, and product release support.
- Working knowledge of FDA, EMA, and cGMP regulations.
- Expertise in contamination control, root cause analysis, technical writing, documentation review, communication, and continuous improvement.
Culture & Benefits
- Mission-driven work focused on developing cancer immunotherapies and creating durable patient responses.
- Environment emphasizing inclusion, employee development, accountability, quality, compliance, and continuous improvement.
- Company-sponsored medical, dental, vision, and life insurance plans.
- Paid time off and potential discretionary annual bonus and stock-based long-term incentives.
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