Analytical Development Scientist
Kelly® Science & Clinical is seeking an Analytical Development Scientist for a contract position at a cutting-edge in Vacaville, CA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust the experts in Science & Clinical recruiting.
Pay: $54-68/hour
Schedule: Mon-Fri Onsite
Overview
The Client is an industry-leading organization focused on the discovery, development, and manufacturing of innovative biologic therapies. In this role, you will support analytical method development, optimization, and validation activities used for GMP testing of biological products. You will also perform biochemical, physical, and chemical analyses in support of process development, lot release, and stability programs while working in compliance with cGMP guidelines.
Responsibilities
- Develop, optimize, and validate analytical methods (e.g., HPLC, capillary electrophoresis, subvisible particles testing).
- Perform biochemical, physical, and chemical analyses of process development, lot release, and stability samples under cGMP conditions.
- Validate analytical test methods in accordance with ICH Q2(R2).
- Author SOPs, protocols, and reports for analytical method development and validation activities.
- Conduct OOS, OOE, and OOT investigations related to testing performed.
- Initiate and author deviations and laboratory investigations as required.
- Provide technical support and troubleshooting for analytical methods and instrumentation.
- Collaborate cross-functionally with R&D, QA, and Manufacturing teams.
- Maintain laboratory operations in an inspection-ready state and ensure compliance with regulatory requirements.
- Train analysts on analytical methods, procedures, and best laboratory practices.
Qualifications
- B.S. or B.A. in Biology, Biochemistry, Chemistry, or a related scientific field.
- Minimum of 8 years of relevant laboratory experience in analytical development or GMP-regulated environments.
- Strong working knowledge of cGMP regulations, including 21 CFR 210/211, USP, EP, and ICH guidelines.
- Experience with protein analytics, SDS-PAGE, chromatography techniques, and spectrophotometry preferred.
- Familiarity with Chromatography Data Systems (CDS) software such as OpenLab preferred.
- Strong analytical, problem-solving, and troubleshooting skills.
- Ability to work independently with minimal supervision and collaboratively in a team environment.
What Happens Next
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. Even if this position doesn’t work out, you’ll remain part of the Client’s talent network—giving our expert Science & Clinical recruiters continued access to your profile and future opportunities.
