Analytical Development Scientist, Biologics

Kelly; Vacaville (CA); On-site; USD 68,880 - 96,432; Full time

Job summary

A global biopharmaceutical company seeks an Analytical Development Scientist for a contract-to-hire role in Vacaville, CA. You will develop and validate analytical methods for biological products, ensuring compliance with cGMP standards while collaborating with cross-functional teams. Ideal candidates should possess a B.S./B.A. in a scientific field and 8+ years of lab experience. This role offers an opportunity to significantly impact oncology treatments and advance your career in a reputable organization.

Qualifications

• 8+ years of relevant laboratory experience preferred.
• Deep understanding of cGMP regulations and laboratory compliance.
• Proficiency in HPLC and protein analytics.

Responsibilities

• Develop, optimize, and validate analytical methods.
• Ensure compliance with ICH Q2(R2) and regulatory guidance.
• Collaborate with teams in R&D, QA, and manufacturing.
• Conduct analyses following cGMP requirements.
• Maintain an inspection-ready laboratory environment.

Skills

cGMP regulations

analytical problem-solving

collaboration

documentation skills

lab instrument proficiency

protein analytics

HPLC

Education

B.S./B.A. in biology, biochemistry, chemistry, or related

Tools

HPLC

subvisible particle analysis

Chromatography Data Systems (OpenLab)

SDS-PAGE

Job description

Kelly® Science & Clinical is seeking an Analytical Development Scientist for a contract-to-hire opportunity with one of our clients, a global biopharmaceutical company focused on oncology in Vacaville, CA. If you are driven by the prospect of translating cutting‑edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

Position Title: Analytical Development Scientist

Position Type: 6‑month Contract

Pay rate: $50-70 per hour

Are you passionate about advancing the frontier of cancer treatment? An industry‑leading biotech organization with global operations is seeking an exceptional Analytical Development Scientist to support the development and delivery of pioneering oncology therapies. Their flagship biologic candidate is currently undergoing late‑stage clinical trials in multiple cancer indications—offering an exciting opportunity to make a tangible impact in the fight against cancer.

This organization is recognized for its end‑to‑end capabilities in drug development, spanning innovative research, clinical programs, and state‑of‑the‑art cGMP manufacturing. With facilities in the United States and Asia, a commitment to scientific excellence drives integrated development strategies that bring transformative medicines to patients worldwide.

Role Overview

As an Analytical Development Scientist, you will play a critical role in the development, optimization, and validation of advanced analytical methods for GMP testing of biological products. Your expertise will support rigorous evaluations of process development, lot release, and stability samples, adhering to the highest cGMP standards. You’ll be empowered to expand your skills with training in cutting‑edge analytical techniques, all while operating in a safety‑focused laboratory environment.

Responsibilities

• Develop, optimize, and validate analytical methods (including HPLC, capillary electrophoresis, and subvisible particle analysis).
• Ensure test methods comply with ICH Q2(R2) and global regulatory guidance.
• Collaborate with cross‑functional teams spanning R&D, QA, and manufacturing.
• Author SOPs, protocols, and comprehensive reports for method development and validation.
• Conduct analyses of test samples, following cGMP requirements and project timelines.
• Provide technical support and troubleshooting for analytical testing methods.
• Investigate and document OOS/OOE/OOT events and laboratory deviations.
• Maintain an inspection‑ready laboratory environment.
• Pursue proficiency in a broad array of test methods and mentor fellow analysts.
• Lead procedural revisions and author Change Control records.
• Uphold rigorous compliance with cGMP, 21CFR, USP, EP, ICH, and other regulatory standards.

Skills & Expertise

• Deep understanding of cGMP regulations and laboratory compliance.
• Exceptional analytical, problem‑solving, and troubleshooting abilities.
• Ability to execute assignments independently or collaboratively.
• Advanced documentation and communication skills—both written and verbal.
• Proficiency in the operation and maintenance of laboratory instruments and computers (Windows, Microsoft Word, Excel).
• Experience with protein analytics, SDS‑PAGE, HPLC separations, Chromatography Data Systems (OpenLab), subvisible particle analysis (USP <788>), and spectrophotometry preferred.
• Physical ability to occasionally lift and move up to 25 pounds; strong vision and focus required.

Qualifications

• B.S./B.A. in biology, biochemistry, chemistry, or a related scientific field.
• Minimum of 8 years’ relevant laboratory experience preferred.

Take Your Career to the Next Level

Contribute to oncology breakthroughs that have the potential to transform lives around the globe. If you are dedicated to scientific excellence and aspire to work at the forefront of biotechnology, we invite you to apply and become part of a world‑class team.