Job Description

Technical Responsibilities

• Method Development: Under supervision, perform development, qualification, and validation of cell-based analytical test methods for drug products and drug substances.
• Assay Execution: Experience performing tissue culture-based potency assays and ELISAs. Experience growing and maintaining cells in microplates.
• Laboratory Support: Maintain multiple cell lines, prepare solutions/culture media, and utilize automation and advanced pipetting techniques. Experience with cell counting, cell viability, transfection, curve fitting, etc.
• Technical Resource: Under guidance, serve as a laboratory hands-on resource to execute complex technical procedures.

Quality, Compliance & Documentation

• Regulatory Oversight: Ensure strict adherence to GXP (GMP/GLP) compliance; interface with QA and other regulatory agencies as needed. Experience with GMP regulations.
• Scientific Review: Serve as data reviewer for scientific rigor, draft and review reports.
• Technical Writing: Author development and validation reports, method SOPs, , and procedures; maintain accurate records and ensure the integrity of all laboratory work.
• Accountability: Take ownership of reporting errors, deviations, or Out of Specification (OOS) occurrences promptly.

Essential Skills & Attributes

• Communication: Excellent oral and written communication skills for technical writing, client interaction, and professional peer engagement.
• Computer Literacy: Advanced proficiency in Excel (formulas and linking spreadsheets) and general scientific software.
• Professionalism: High attention to detail, self-motivated, adaptable, and willing to work overtime when necessary to meet group deadlines.

Qualifications

• Degree: Bachelor’s in biology, biochemistry, chemistry, or a related physical science.
• Experience Levels: Bachelor’s with 3 to 7 years of related experience.
• Authorization: Must be authorized to work in the U.S. indefinitely without sponsorship.

Additional Information

Position is full-time, first shift Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.

The pay range of this role is $65,000 - $80,000 depending on related experience.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.