обновлено 2 дня назад
Manager, Quality Control (Biotech)
117 800 - 176 800$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Quality Control (Biotech): Overseeing analytical testing and reporting for in-process, release, and stability samples across manufacturing and laboratory centers with an accent on cGMP compliance, laboratory operations, and quality systems. Focus on managing QC personnel, troubleshooting analytical methods, leading investigations and continuous improvement, and coordinating cross-functional laboratory activities.
Location: Boston, MA, United States; on-site five days per week. Third shift: Wednesday through Saturday, 9:00 p.m. to 9:00 a.m.
Base salary: $117,800–$176,800 annually, plus eligibility for an annual bonus and annual equity awards.
Company
Vertex is a global biotechnology company focused on scientific innovation and developing better outcomes for patients.
What you will do
- Oversee analytical testing and reporting for in-process, release, and stability samples across the Vertex Manufacturing Center and Leiden Center.
- Manage laboratory programs and processes including assay readiness, training, sample management, data review, and reporting.
- Coordinate laboratory activities, track commitments and metrics, and ensure timely delivery.
- Lead or support troubleshooting of analytical methods and equipment, as well as OOS, OOT, and deviation investigations.
- Review and approve data and SOPs while ensuring laboratory records meet cGMP and GDP expectations.
- Coach and develop direct reports and represent Quality Control in cross-functional teams and vendor collaborations.
Requirements
- Bachelor’s degree in science or a related discipline, with 8 years of pharmaceutical or biopharmaceutical industry experience, or an equivalent combination of education and experience.
- Prior Quality Control management experience and formal people management responsibility.
- Knowledge of US and EU cGMP regulations and guidance, with experience supporting regulatory agency inspections.
- Strong knowledge of analytical methodologies including flow cytometry, cell counting and viability, sterility, endotoxin testing, and cell culture.
- Strong verbal and written communication, prioritization, flexibility, and attention to detail.
- Ability to work on-site in Boston five days per week on the Wednesday–Saturday night shift.
Culture & Benefits
- Continuous learning and opportunities to stay informed about AI, technology, automation, and industry trends.
- Medical, dental, and vision benefits with paid time off and company shutdowns in summer and winter.
- Educational assistance, including student loan repayment programs.
- Commuting subsidy, matching charitable donations, and 401(k) benefits.
- Inclusive workplace committed to equal employment opportunity and reasonable accommodations.
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