Analytical Development Scientist

Kelly; Los Angeles (CA); On-site; USD 120,000 - 135,000; Full time

Job summary

Kelly is seeking an Analytical Development Scientist for an on-site role in the Los Angeles area. The position focuses on developing cell-based, ELISA, HPLC, and CE methods to characterize protein biologics and support validation, process development, and stability studies in GMP and non-GMP environments.

The role interfaces with PM, QC, MFG, and external clients, leading testing and data analysis, authoring SOPs, and contributing to continuous improvement initiatives.

Qualifications

• BS degree in Biochemistry, Chemistry, Biology, or a related field.
• 8+ years of biotech industry experience working in a QC or analytical lab.
• Experience with analytical testing, GMPs, and regulatory audits.
• HPLC, CE, or Potency/ELISA experience is essential.
• Protein characterization, electrophoresis, chromatography, and assay validation.

Responsibilities

• Develop, perform, troubleshoot, and review routine wet chemistry/ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/CE) and/or HPLC.
• Research, analyze, and report data with scientific justification and under supervision.
• Train/supervise junior analysts and prepare technical reports for senior personnel.
• Manage client projects and collaborate with MFG, QC, PM; provide scientific insights for decisions.
• Develop, review, revise, and write test methods, forms, SOPs, and related documents.
• Act as SME for QC and support regulatory inspections.

Skills

HPLC

ELISA

Cell-based assays

SDS-PAGE

Education

BS in Biochemistry/ Chemistry/ Biology

Tools

GMP knowledge

Job description

Kelly® Science & Clinical is seeking an Analytical Development Scientist opportunity with one of our clients, a leading biologics CDMO in the Los Angeles, CA area. 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 industry.

Workplace: Onsite in the Los Angeles area

Position Title: Analytical Development Scientist

Position Type: Direct hire

Salary range: 120,000-135,000 per year

Your Role

In the Scientist, Analytical Development role, you will have the opportunity to focus on developing cell-based, ELISA, HPLC, and/or CE methods and other analytical techniques to identify and characterize protein biologics. This position offers the chance to interface with project management, Process Development, Quality Control, as well as to interface with external clients. The Scientist will lead testing and sampling to support validation, process development, and stability studies in a non-GMP and GMP environment. The individual will take a product through method development and eventually transfer to a quality control department in a GMP environment. They will have a substantial understanding of the job and apply knowledge and skills to complete a wide range of tasks, as well as support and lead continuous improvement initiatives.

Key Responsibilities

• Develop, perform, troubleshoot, and review routine wet chemistry/ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/CE/Maurice) and/or HPLC. May be designated as study lead for validation projects, investigations, and method development projects.
• Must use scientific reasoning when making decisions regarding the quality of the data reported. Expected to research/gather information without supervision and to make scientifically sound decisions based on knowledge and experience.
• Train/supervise the experimental work of more junior analysts. Tabulate and graph data, and prepare technical reports for senior personnel. Review technical data and reports written by less experienced personnel.
• Manage client projects and collaboration with other functional areas including but not limited to MFG, QC, and PM. Provide scientific insights for the joint team to make project decisions.
• Develop, review, revise, and write test methods, forms, templates and standard operating procedures, and other related documents.
• Actively support the QC department as the Subject Matter Expert (SME).
• Knowledge of company cGMPs as well as industry regulations that apply to job functions. Participate in regulatory inspections.
• Other tasks as assigned.

Minimum Qualifications

• BS degree in Biochemistry, Chemistry, Biology, or a related field is required.
• 8+ years of biotech industry experience working in a QC or analytical lab.
• Previous experience with analytical testing and equipment utilizing analytical biochemistry methods, writing reports/procedures/specifications, GMPs, and regulatory audits required.
• HPLC, CE, or Potency/ELISA experience is essential.
• Should also have experience with protein characterization, electrophoresis, chromatography, and assay validation/qualification.

Compensation

Our client offers competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.