What are the responsibilities and job description for the Lead Microbiologist position at Tailstorm Health Inc?
Job Title: Lead Microbiologist
Location: Chandler and DV
Job Type: Full-time
Company:
About Us:
Medivant is a leading pharmaceutical company dedicated to improving patient outcomes through innovative research and development. We are committed to advancing healthcare by delivering high-quality products and solutions. Our team is comprised of passionate professionals who thrive in a collaborative environment, and we are currently seeking a Lead Microbiologist to join our dynamic team.
**Job Summary:**
As the Lead Microbiologist, you will play a critical role in ensuring the safety, efficacy, and quality of our pharmaceutical products. You will oversee microbiological testing and quality control processes, lead a team of microbiologists, and collaborate with cross-functional teams to support product development and regulatory compliance. Your expertise will be essential in driving microbial risk assessments, contamination control strategies, and continuous improvement initiatives.
Key Responsibilities:
- Lead and manage the microbiology team, providing guidance, mentorship, and training to ensure high standards of performance and professional development.
- Design, implement, and validate microbiological testing methods and protocols in accordance with regulatory guidelines (e.g., FDA, EMA, USP).
- Oversee microbiological testing of raw materials, in-process samples, and finished products to ensure compliance with established specifications and quality standards.
- Conduct risk assessments related to microbial contamination and develop effective control strategies to mitigate risks in manufacturing and laboratory environments.
- Collaborate with R&D, Quality Assurance, and Production teams to support product development, stability studies, and troubleshooting of microbiological issues.
- Review and approve microbiology-related documentation, including protocols, reports, and standard operating procedures (SOPs).
- Maintain up-to-date knowledge of industry trends, regulatory changes, and advancements in microbiology techniques and technologies.
- Lead investigations into microbiological deviations, out-of-specification results, and product recalls, ensuring timely resolution and implementation of corrective actions.
- Prepare and present findings to internal stakeholders and regulatory agencies as needed.
Qualifications:
- Ph.D. or Master’s degree in Microbiology, Biotechnology, or a related field.
- Minimum of 10 years of experience in microbiology within the pharmaceutical or biotechnology industry, with a focus on quality control and assurance.
- Proven experience in leading and managing teams, with strong interpersonal and communication skills.
- In-depth knowledge of microbiological testing methods, regulatory requirements, and industry best practices.
- Experience with aseptic techniques, environmental monitoring, and sterility assurance programs.
- Strong analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions.
- Proficiency in using laboratory equipment and microbiological software tools.
- Ability to work collaboratively in a fast-paced, cross-functional environment.
What We Offer
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- A collaborative and innovative work environment.
- The chance to make a significant impact in the pharmaceutical industry.
