Associate Scientist, Analytical Development Location: Tustin, CA Position Summary We are seeking an experienced Associate Scientist, Analytical Development to support analytical method development, qualification, validation, and transfer activities for biologic products. This role focuses on the characterization of protein therapeutics using a variety of analytical techniques and partners closely with Process Development, Quality Control, Quality Assurance, Manufacturing, and other cross-functional scientific teams. The successful candidate will contribute to analytical testing, method optimization, stability studies, and technology transfer activities while ensuring compliance with cGMP requirements and industry regulations. Key Responsibilities • Perform and review analytical testing using HPLC, Capillary Electrophoresis (CE), ELISA, cell-based assays, SDS-PAGE, and other protein characterization techniques. • Develop, optimize, qualify, validate, and transfer analytical methods supporting biologic product development. • Design and execute studies supporting process development, comparability assessments, and stability programs. • Analyze experimental data and make scientifically sound decisions regarding data quality and interpretation. • Author and revise analytical methods, protocols, reports, specifications, and standard operating procedures (SOPs). • Support method transfers into Quality Control laboratories and provide technical expertise during implementation. • Participate in investigations, deviation assessments, CAPAs, and continuous improvement initiatives. • Collaborate across multiple functions to support development and commercialization activities. • Support regulatory inspections, audits, and GMP compliance activities. • Mentor junior laboratory staff and provide technical guidance when appropriate. Required Qualifications • Bachelor’s degree in Biochemistry, Chemistry, Biology, Biotechnology, or a related scientific discipline. • Minimum of 5 years of experience in Biotechnology, Biopharmaceutical, CDMO, Analytical Development, or Quality Control laboratory environments. • Experience supporting biologics, protein therapeutics, recombinant proteins, monoclonal antibodies, or other large-molecule products. • Hands-on experience with at least one or more of the following analytical techniques: - HPLC - Capillary Electrophoresis (CE) - ELISA - Potency Assays - Cell-Based Assays • Experience with protein characterization, chromatography, electrophoresis, assay development, assay qualification, and assay validation. • Strong understanding of GMP/cGMP regulations and regulated laboratory environments. • Experience writing reports, specifications, technical documents, and laboratory procedures. Preferred Qualifications • Experience within a biologics CDMO environment. • Experience supporting monoclonal antibody (mAb) or recombinant protein programs. • Experience leading validation studies, investigations, technology transfer, or analytical development projects. • Exposure to client interactions and regulatory inspections. • Experience supporting stability studies and method lifecycle management. • Experience training or mentoring junior scientists and analysts. Ideal Candidate Profile • Strong scientific reasoning and data-driven decision-making abilities. • Excellent analytical and problem-solving skills. • High attention to detail and commitment to quality. • Ability to collaborate effectively across departments and project teams. • Strong written and verbal communication skills. • Ability to manage multiple priorities in a fast-paced environment. • Demonstrated ownership, accountability, and continuous improvement mindset. Preferred Industry Background • Biologics • Monoclonal Antibodies (mAbs) • Recombinant Proteins • Protein Therapeutics • Analytical Development • Biopharmaceutical Manufacturing • Drug Substance Development • GMP/cGMP Laboratories • CDMO Environment • CHO/Mammalian Cell-Based Products • Technology Transfer • Stability Studies Recruiter Summary Looking for an Analytical Development scientist with 5+ years of biotech or biopharmaceutical experience and strong expertise in HPLC, CE, ELISA, potency assays, or cell-based assays. Ideal candidates will have experience supporting biologics, monoclonal antibodies, recombinant proteins, protein characterization, assay validation, and GMP-regulated environments. Applicants must be legally authorized to work in the United States for any employer. Sponsorship is not available for this position now or in the future.
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