Senior Manager, Microbiology Support for Global ASAT [Remote]

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.

Requirements:

• 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.

Benefits:

• 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.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.