Position Summary
The Associate Director of Microbiology will provide strategic and hands-on leadership for microbiology activities supporting discovery, development, manufacturing, and commercialization of pharmaceutical products. This role is critical in a fast-growing biotech environment and will oversee microbiological testing, contamination control, method development/validation, and regulatory compliance across clinical and commercial programs.
The ideal candidate brings deep technical expertise, strong people leadership, and the ability to scale microbiology capabilities in preparation for late-stage development and IPO readiness.
Essential Responsibilities:
Scientific & Technical Leadership
- Lead all microbiology functions including:
- Environmental monitoring
- Sterility testing
- Bioburden and endotoxin testing
- Microbial identification
- Method development, validation, and transfer
- Provide subject matter expertise for microbiology strategy across R&D, CMC, QA, and manufacturing.
- Support formulation development, stability programs, and container-closure integrity from a microbiological perspective.
- Evaluate and implement new microbiological technologies and testing approaches.
Regulatory & Compliance
- Ensure microbiology operations comply with cGMP, FDA, EMA, and ICH requirements.
- Serve as microbiology lead during regulatory submissions (IND, NDA/ANDA, BLA) 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.
Cross-Functional Collaboration
- Partner closely with Quality Assurance, Manufacturing, Technical Operations, and external CDMOs.
- Provide microbiology input for deviation investigations, CAPAs, change controls, and risk assessments.
- Support tech transfer activities internally and with external manufacturing partners.
Team Leadership & Scaling
- 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.
Vendor & Budget Management
- Manage external microbiology laboratories, consultants, and service providers.
- Develop and manage departmental budgets and forecasting.
- Ensure cost-effective solutions while maintaining quality and compliance.
Qualifications:
Education
- MS in Microbiology, Biology, Pharmaceutical Sciences, or a related discipline preferred
- BS with significant industry experience may be considered
Experience:
- 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
Technical Expertise
- 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 labs
Leadership & Personal Attributes
- Strategic thinker with hands-on execution capability
- Strong communication and influencing skills
- Comfortable operating in ambiguity and fast-paced environments
- High integrity, collaborative mindset, and strong attention to detail
Why Join Us?
We are a fast-growing pharmaceutical startup dedicated to innovation and improving patient outcomes. Join us to gain hands-on experience in a growing pharmaceutical business, get exposure to various functions with opportunities for career development and work in a collaborative and supportive work environment.