What are the responsibilities and job description for the Manager of Analytical Development position at AL Solutions?
About the Job
Manager, Analytical & Microbiology Development
Drive analytical and microbiology excellence in a growing biotech environment. As Manager, Analytical & Microbiology Development, you’ll lead method development, validation, and microbiological testing strategies, ensuring compliance and supporting drug development. Reporting to the Director of Analytical Sciences, you’ll collaborate cross-functionally to optimize analytical and microbiology capabilities.
What You’ll Do:
- Lead method development, validation, and transfer for biopharmaceuticals and microbiological testing
- Oversee analytical and microbiology testing, data integrity, and compliance (cGMP, ICH, USP)
- Manage lab resources, personnel, and project timelines
- Support regulatory submissions and audits
- Drive continuous improvement in analytical and microbiological processes
What We’re Looking For:
- 8 years in analytical and microbiology development within pharma/biotech
- Expertise in HPLC, UPLC, GC, LC-MS, ICP-MS, and microbiological testing methods (USP <51>, <61>, <62>, <71>, <85>, <1116>)
- Strong knowledge of cGMP, ICH guidelines, and regulatory requirements
- Leadership experience with a track record of mentoring teams
- Strong problem-solving and technical writing skills
Why Join Us?
- Competitive salary and benefits
- Career growth in a dynamic, fast-paced environment
- Opportunity to impact biopharmaceutical and microbiology innovation
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