5 дней назад
Supervisor, QC Microbiology (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Supervisor, QC Microbiology (Biotechnology): Supervising quality control microbiology laboratory operations supporting cell therapy manufacturing with an accent on microbiological testing, cGMP compliance, method validation, and laboratory investigations. Focus on leading staff, troubleshooting complex laboratory issues, managing non-conformances, and coordinating QC activities with Quality Assurance, Manufacturing, Engineering, and Technical Operations.
Location: Onsite in Raritan, New Jersey, United States. Occasional travel to partner sites in New Jersey or Pennsylvania may be required.
Company
is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and NK cell-based treatments for serious diseases.
What you will do
- Supervise quality control microbiology laboratory operations and daily personnel activities supporting cell therapy manufacturing.
- Oversee raw material, in-process, environmental, utility, and product release testing.
- Review and approve laboratory data, investigate deviations and invalid assays, and troubleshoot complex laboratory issues.
- Develop, verify, qualify, validate, transfer, and implement microbiology test methods.
- Maintain, calibrate, and qualify laboratory instruments and equipment.
- Manage staff development, departmental resources, staffing plans, budgets, and cross-functional QC initiatives.
Requirements
- Bachelor’s degree in science, engineering, or an equivalent technical discipline.
- At least 6 years of relevant experience and at least 1 year of leadership experience.
- Experience with people management, quality systems, chemical, biochemical, and microbiological concepts.
- Knowledge of cGMP regulations, FDA and EU guidance, statistics, and laboratory data evaluation.
- Ability to work with inspectors and collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering, Maintenance, Supply Chain, and Planning.
- Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify. The role requires unplanned overtime, including nights and weekends, when necessary.
Nice to have
- Experience in an aseptic manufacturing facility, quality control, quality assurance, or cell therapy.
- Experience in clinical quality, method development, cell banking, research and development, or clinical manufacturing and NPI support.
Culture & Benefits
- Collaborative work with quality and operational functions across the organization.
- Work governed by safety policies, quality systems, and cGMP requirements.
- Permanent full-time employees are eligible for company benefits; contractors are not eligible for benefits through .
- The role involves routine exposure to biological materials and hazardous chemicals.
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