Associate Director of Microbiology

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.