What are the responsibilities and job description for the Microbiology Lead position at Tailstorm Health Inc?
Medivant Healthcare is a leading 503b pharmaceutical outsourcing facility dedicated to providing high-quality, ready-to-administer injectable medications. With state-of-the-art facilities in Chandler and Deer Valley, Arizona, we are committed to maintaining the highest standards of sterility, compliance, and operational excellence. Our mission is to enhance patient care by ensuring a reliable supply of critical medications while adhering to stringent FDA regulations and cGMP requirements.
We are looking for a highly skilled and experienced Assistant Director of Microbiology to lead our microbiology laboratory operations, supporting both our Chandler and Deer Valley facilities. This role will be based primarily in Chandler, Arizona, with flexibility for commuting to the Deer Valley facility as needed. As a key leader in our organization, the selected candidate will be responsible for ensuring compliance with regulatory standards and driving microbiological excellence across both locations. This position will report administratively to the Lab Director and functionally to the VP of Quality. This is an exciting leadership opportunity in a fast-paced 503b pharmaceutical environment. If you are a motivated microbiology professional seeking a dynamic leadership role, we encourage you to apply!
Educational Requirements:
Technical Expertise:
- 10–14 years of experience in a pharmaceutical microbiology laboratory, specializing in API and finished drug products, with a strong focus on injectables and pre-filled syringes.
- Hands-on expertise in Sterility, Bioburden, Bacterial Endotoxins, Disinfectant Efficacy Testing, Environmental Monitoring, and WFI testing.
- Strong background in microbiological validation including sterilization processes, cleanroom qualification, and media fill studies.
- Ability to meet aseptic gowning requirements and work within a controlled cleanroom environment.
- In-depth knowledge of FDA guidance, 21 CFR standards, and USP microbiological testing monographs.
- Prior USFDA audit experience is preferred.
- Proficient in drafting protocols, SOPs, root cause analyses, CAPAs, and investigation reports.
- Strong decision-making skills with a team-oriented, goal-driven, and collaborative approach.
- Proven ability to lead and develop a microbiology team, ensuring compliance with company and regulatory standards.
- Strong communication and collaboration skills to work cross-functionally with QA, ENG, Manufacturing, and other departments.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) with experience in trend analysis and data visualization.
This is an excellent opportunity for an experienced microbiology professional to take on a leadership role in a fast-paced and highly regulated environment. If you are passionate about microbiological quality and compliance, we encourage you to apply!
