1 день назад
Sr Manager QC Microbiology
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr Manager QC Microbiology (QC Microbiology): Leading QC Microbiology and PCR laboratory operations at an advanced biomanufacturing site with an accent on environmental monitoring, clean utilities monitoring, microbial identification, and microbiological product testing. Focus on building high-performing teams, maintaining cGMP compliance, overseeing investigations and validation activities, and advancing Lean and continuous improvement initiatives.
Location: Holly Springs, North Carolina, United States
Company
is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Lead the QC Microbiology organization at an advanced biomanufacturing site, with accountability for safety, quality, compliance, people, and operational performance.
- Oversee environmental monitoring, clean utilities monitoring, microbial identification, PCR, and in-process, release, stability, and routine microbiological testing.
- Build, coach, and develop a diverse team while strengthening technical capability, succession planning, and career development.
- Provide technical oversight for investigations, deviations, CAPAs, change controls, trends, validation, qualification activities, methods, and laboratory systems.
- Represent QC Microbiology during regulatory inspections, audits, and quality oversight activities.
- Partner with Quality, Manufacturing, Engineering, Regulatory, Technical Development, and the global QC network to improve microbiological control strategies and laboratory performance.
Requirements
- High school diploma/GED with 12 years of Quality or Aseptic Manufacturing experience; associate degree with 10 years; bachelor’s degree with 8 years; master’s degree with 6 years; or doctorate with 2 years.
- At least 2 years of direct people management or leadership experience managing teams, projects, programs, or resource allocation.
- Leadership experience in a GMP pharmaceutical, biotechnology, or aseptic manufacturing environment.
- Experience with QC Microbiology, environmental monitoring, clean utilities monitoring, and/or molecular testing operations.
- Strong knowledge of microbiological control, aseptic technique, and cGMP requirements.
- Experience supporting regulatory inspections and working with regulatory agencies.
Nice to have
- Advanced degree in Microbiology, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline.
- Experience driving Lean, continuous improvement, digital transformation, or operational excellence.
- Ability to translate complex technical data into decisions and actions.
- Strong collaboration, influencing, and communication skills in a global matrixed organization.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
- Retirement and savings plan with company contributions.
- Annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
Hiring process
- Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
- Sponsorship for the role is not guaranteed.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
5 дней назад
Microbiologist II - Non-Sterile
23 часа назад
Supervisor, Quality Control (Microbiology)
54 200 - 103 200$
5 дней назад
Microbiologist II - Non-Sterile (Biotech)
7 дней назад
Quality Control Microbiology Analyst (Biopharma)
27 - 42$
5 дней назад
Microbiologist II - Sterile
2 дня назад
Principal Analytical Sciences Scientist (Biotechnology)
108 000 - 176 000$