Associate Director of Microbiology
About The Position
The Associate Director of Microbiology provides strategic and hands-on leadership for microbiology activities supporting pharmaceutical product discovery, development, manufacturing, and commercialization. The role oversees microbiological testing, contamination control, method development and validation, and regulatory compliance across clinical and commercial programs. It supports the expansion of microbiology capabilities for late-stage development and IPO readiness. The Associate Director leads microbiology functions and provides expertise across R&D, CMC, Quality Assurance, and manufacturing. The role also leads regulatory readiness and interactions, collaborates with internal teams and external manufacturing partners, builds and mentors a microbiology team, and manages external laboratories and departmental budgets.
Requirements
- 5–10+ years of progressive microbiology experience in biotech or pharmaceutical environments.
- Demonstrated leadership of microbiology teams and external vendors.
- Direct experience supporting late-stage development and/or commercial manufacturing.
- Hands-on experience with FDA inspections and regulatory submissions.
- Strong knowledge of cGMP microbiology practices.
- Experience with aseptic processing and contamination control.
- Familiarity with USP, EP, and ICH guidelines.
- Experience working with CDMOs and contract laboratories.
- Strategic thinking and hands-on execution capability.
- Strong communication and influencing skills.
- Comfort operating in ambiguous and fast-paced environments.
- High integrity, a collaborative mindset, and strong attention to detail.
Nice To Haves
- MS in Microbiology, Biology, Pharmaceutical Sciences, or a related discipline preferred.
- A BS with significant industry experience may be considered.
Responsibilities
- Lead environmental monitoring, sterility testing, bioburden and endotoxin testing, microbial identification, and method development, validation, and transfer.
- Provide microbiology strategy and subject matter expertise across R&D, CMC, Quality Assurance, and manufacturing.
- Support formulation development, stability programs, and container-closure integrity from a microbiological perspective.
- Evaluate and implement new microbiological technologies and testing approaches.
- Ensure microbiology operations comply with cGMP, FDA, EMA, and ICH requirements.
- Serve as microbiology lead for regulatory submissions, including IND, NDA/ANDA, and BLA submissions, and agency interactions.
- Lead microbiology readiness and participation for FDA inspections, audits, and partner due diligence.
- Author, review, and approve SOPs, protocols, reports, and regulatory documentation.
- Partner with Quality Assurance, Manufacturing, Technical Operations, and external CDMOs.
- Provide microbiology input for deviation investigations, CAPAs, change controls, and risk assessments.
- Support technology transfer activities internally and with external manufacturing partners.
- Build, mentor, and lead a high-performing microbiology team.
- Define staffing plans, training programs, and succession planning aligned with company growth.
- Foster a culture of scientific rigor, accountability, and continuous improvement.
- Manage external microbiology laboratories, consultants, and service providers.
- Develop and manage departmental budgets and forecasting.
- Ensure cost-effective solutions while maintaining quality and compliance.
Benefits
- Opportunities for career development.
- Collaborative and supportive work environment.
- Hands-on experience in a growing pharmaceutical business.
- Exposure to various functions.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
