Senior Manager, Microbiology Support for Global ASAT
Job Description
Team: Others
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Manager, Microbiology Support for Global ASAT in United States.
This role sits within a global Analytical Science and Technology environment focused on advancing high-quality vaccine development from clinical stages through commercialization. It plays a critical part in ensuring microbiological quality control across GMP operations, supporting both internal laboratories and external testing partners. The position is highly cross-functional, interfacing with analytical development, quality control, and manufacturing teams to ensure compliance and scientific rigor. It offers a strong blend of technical leadership and operational oversight within aseptic manufacturing and microbiological testing. The role directly contributes to product quality, regulatory readiness, and continuous improvement in a fast-paced biotech setting. It is ideal for a senior microbiology professional who thrives in a highly regulated, innovation-driven environment with global collaboration.
Accountabilities:
- Serve as the subject matter expert for microbiological QC assays, ensuring technical excellence and compliance across all testing activities.
- Oversee GMP microbiological testing operations, including coordination with contract testing organizations and internal QC laboratories.
- Lead quality event management activities, including deviations, investigations, change controls, and CAPA implementation related to microbiology and aseptic processes.
- Support authoring and review of SOPs, regulatory documentation (including BLA sections), and technical method documentation.
- Manage outsourced analytical and characterization testing supporting lot release and clinical/commercial product development.
- Collaborate cross-functionally with Analytical Development, Quality Control, MSAT, and external partners to ensure method alignment and data integrity.
- Drive continuous improvement initiatives and foster a strong culture of quality and compliance across microbiology operations.
- Advanced degree in Microbiology, Biology, Biochemistry, or related field, with 7+ years (PhD), 9+ years (MS), or 11+ years (BS) of relevant experience.
- Minimum 7+ years in pharmaceutical or biotech environments, with strong exposure to aseptic manufacturing and microbiological QC.
- Strong expertise in microbial testing methods such as bioburden, endotoxin, sterility, and growth promotion assays.
- Experience with GMP systems, regulatory frameworks (FDA, EU, ICH), and compendial standards (USP/EP/JP).
- Proven track record in investigations, deviation management, OOS resolution, and CAPA development.
- Experience with method validation, verification, transfer, and analytical lifecycle management is highly desirable.
- Strong communication, leadership, and stakeholder management skills in global, cross-functional environments.
- Ability to manage multiple priorities, work independently, and operate effectively in complex, regulated settings.
- Competitive salary package aligned with experience and location
- Equity-based compensation component
- Comprehensive health, dental, and vision insurance coverage
- Flexible work arrangements, including remote options depending on role needs
- Opportunities to work on advanced vaccine programs with global impact
- Career development within a high-growth, innovation-driven biotech environment
- Inclusive, collaborative, and science-led workplace culture.
Requirements:
Benefits:
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Date Posted
05/28/2026
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