Senior Formulation Scientist
6 days ago
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from discovery stage R&D work to manufacturing services for cell, gene, and mRNA-based therapeutics.
The ideal candidate will have a strong background in analytical chemistry and experience with HPLC instrumentation for GLP use. The role will involve developing, optimizing, and qualifying analytical procedures, as well as collaborating with internal and external clients to meet their needs.
Key Responsibilities:- Develop and optimize analytical procedures using Agilent 1260/1290 Infinity II Bio LC Systems with DAD, Fluorescence, and ELSD detectors.
- Qualify and validate new instrumentation for GLP use.
- Collaborate with Study Operations and Quality Assurance to execute protocols for analytical procedure development, qualification/validation, and technology transfer.
- Write procedures for formulation preparation and perform routine and non-routine analytical testing methods.
- Maintain high-quality execution and documentation required by GLP and other regulatory agencies.
- Masters degree in chemistry, biochemistry, or related field of study with minimum 10 years of experience in a related field.
- Doctoral Degree with a minimum 4 years of experience in a chemistry laboratory operation or analytical development role in a regulated laboratory operation.
- In-depth knowledge of HPLC instrumentation for GLP use, including method development, assay qualification/validation, technology transfer, and troubleshooting.
- Ability to communicate clearly and concisely, both verbally and in writing.
- Competitive compensation package.
- FLEXIBLE PTO policy.
- Generous paid parental leave.
- Wellness and Self-Care Programs.
- Tuition Reimbursement.
- EAP/work-life support system.
- A fun work environment where everyone's voice matters.
- An Opportunity to Change the World.
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