Associate Director of Microbiology

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.

Scientific & Technical Leadership

• Lead all microbiology functions including:
• 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.
• 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.

Qualifications:

Education

• MS in Microbiology, Biology, Pharmaceutical Sciences, or a related discipline preferred
• BSwith 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 guidelinesExperience 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.

Are you authorized to work in the United States? Are you authorized to work in the United States?

Will you now or in the future require sponsorship for employment visa status (e.g., H-1B status)? Will you now or in the future require sponsorship for employment visa status (e.g., H-1B status)?