About this opportunity
Transpire Bio Inc. lists this Associate Director of Microbiology opportunity in town of florida, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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)?
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.