Chemical Analysis Specialist for Preclinical Studies
1 week ago
AmplifyBio Overview
We are a leading contract research organization with a comprehensive range of services spanning discovery, preclinical CRO, and manufacturing services for cell, gene, and mRNA-based therapeutics.
Our ecosystem comprises three business units: ADOC (South San Francisco), ASET (West Jefferson, OH), and AMEC (New Albany, OH). We're committed to growing an inclusive community and hire diverse teams from all backgrounds.
About the Role
We're seeking a Chemical Analysis Specialist in Dose Formulation and Analysis to join our team. As a key member, you'll lead analytical chemistry development projects, collaborating with internal and external clients to develop robust procedures.
The ideal candidate has a strong background in HPLC instrumentation, GLP experience, and excellent communication skills. You'll be responsible for developing, optimizing, qualifying, and validating analytical procedures, as well as ensuring compliance with regulatory requirements.
This role offers a competitive salary, ranging from $120,000 to $170,000 per year, depending on experience, plus benefits including health insurance, flexible PTO, and tuition reimbursement.
Key Responsibilities:
- Lead Analytical Chemistry Development projects and collaborate with clients to develop analytical procedures.
- Qualify and validate new instrumentation for GLP use.
- Write protocols and reports for analytical procedure development, qualification/validation, and technology transfer.
- Develop and maintain laboratory operations systems.
- Ensure compliance with FDA Good Laboratory Practice (GLP) Regulations and other applicable guidelines.
Requirements:
- Masters degree in chemistry, biochemistry, or related field with 10+ years of experience or doctoral degree with 4+ years of experience in a regulated laboratory.
- Strong knowledge of HPLC instrumentation, GLP experience, and excellent communication skills.
- Able to work in a fast-paced environment and adapt to changing priorities.
- Must have a flexible schedule to accommodate non-standard work hours and willing to work more than 40 hours a week when needed.
- Knowledge of FDA's Good Laboratory Practice (GLP) Regulations and ability to work in a BSL-2 research laboratory environment.
Benefits:
- Competitive compensation package ($120,000 - $170,000 per year)
- Flexible PTO policy
- Tuition reimbursement
- Wellness programs
- 401(k) match
- EAP/work-life support system
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