5 часов назад
Senior Manager, Quality Control Analytical (Biotechnology)
145 000 - 159 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Quality Control Analytical (Biotechnology): Managing analytical laboratory testing for fusion proteins, cell therapies, and cancer vaccines with an accent on method development, qualification, transfer, and GMP compliance. Focus on coordinating complex investigations, reviewing protocols and reports, and leading QC analytical staff in an on-site biotechnology laboratory.
Location: On-site in Dunkirk, New York, United States; flexibility for off-hours schedules is required.
Annual base pay: $145,000–$159,500, plus eligibility for a discretionary bonus and equity award.
Company
is a vertically integrated commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and infectious-disease treatments.
What you will do
- Oversee and schedule analytical testing for in-process, suitability-for-use, method development, optimization, transfer, qualification, and investigative studies.
- Lead QC Analytical laboratory staff through hiring, training, one-to-one meetings, and career development.
- Coordinate cross-functional activities as the QC Analytical representative.
- Review assay protocols and reports according to commercial GMP standards.
- Participate in method development, optimization, transfer, and qualification, including protocol drafting, data collection, and report writing.
- Draft and revise SOPs and test methods while ensuring regulatory compliance and data integrity.
Requirements
- Bachelor’s degree in Cell Biology, Immunology, or a related discipline plus 8+ years of relevant biotechnology experience; or a master’s degree in Biology or a related discipline plus 6+ years of relevant experience.
- Relevant experience must emphasize analytical development or quality control testing.
- Experience with QC testing methods and equipment, including HPLC and plate readers.
- Knowledge of cGMP, FDA, and USP regulations, data integrity principles, and basic statistics.
- Ability to work independently and within cross-functional teams to meet project timelines.
- Ability to work on-site in a laboratory environment, gown and enter laboratories, and lift materials weighing up to 20 pounds.
Nice to have
- Experience leading a team in a GMP environment.
- Adaptability under changing circumstances to deliver individual and team results.
- Working knowledge of Microsoft Word, PowerPoint, and Excel.
Culture & Benefits
- Collaborative work across different areas of the organization.
- Professional development opportunities within a growing, publicly traded biopharmaceutical company.
- Medical, dental, and vision plan options, plus health and financial wellness programs.
- 401(k) retirement plan with company match, flexible spending accounts, disability coverage, and life insurance.
- Paid time off, holidays, employee assistance, legal services, identity theft protection, pet insurance, and employee discounts.
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