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Biologics Raw Materials Group Leader
Описание вакансии
Текст:
TL;DR
Biologics Raw Materials Group Leader (Biochemistry/Microbiology): Supervising laboratory operations and microbiological analysis of biologics raw material samples with an accent on cGMP compliance, analytical methods, quality metrics, and personnel leadership. Focus on coordinating laboratory workload, troubleshooting technical problems, reviewing investigations, maintaining calibrated systems, and evaluating microbiological trends.
Location: Columbia, MO, USA; candidates should live within a commutable distance. Full-time, Monday–Friday, 8:00 a.m.–4:30 p.m., with additional hours as needed.
Company
provides analytical testing and laboratory services across food, environmental, pharmaceutical, cosmetic, genomics, clinical, and other life sciences industries.
What you will do
- Supervise daily laboratory activities, scheduling, workload prioritization, and group performance.
- Lead, train, mentor, and support technicians, analysts, and microbiologists.
- Perform and oversee microbiological quality analyses, including microbial enumeration, specified microorganism absence testing, and endotoxin analysis.
- Maintain quality metrics, conduct statistical and root cause analyses, and respond to microbiological trends.
- Coordinate investigations, deviations, technical issues, delays, and corrective solutions with laboratory management and chemists.
- Maintain and calibrate laboratory systems and equipment according to specified requirements.
Requirements
- Bachelor’s degree in chemistry, biochemistry, immunology, biology, chemical engineering, pharmaceutical sciences, or a directly related field, plus five years of relevant experience.
- A relevant master’s degree with three years of directly relevant experience, or a relevant PhD, may substitute for the bachelor’s degree and experience requirements.
- At least five years of relevant biochemistry experience; cell and molecular biology experience is preferred.
- Prior leadership or supervisory experience and hands-on laboratory troubleshooting proficiency.
- Strong knowledge of cGMP requirements, regulatory compliance, USP and EP compendial requirements, and regulated laboratory operations.
- Authorization to work indefinitely in the United States without restriction or sponsorship is required.
Nice to have
- Experience in cell and molecular biology.
- Expertise in chromatography, Empower, SEC, and mass spectrometry.
- Experience with electrophoretic methods, ICP-MS, FTIR, Karl Fischer methodologies, stability studies, method development and validation, LIMS, and electronic laboratory notebooks.
Culture & Benefits
- Comprehensive medical coverage.
- Life and disability insurance.
- 401(k) plan with company match.
- Paid holidays and vacation.
- Dental and vision options.