About this role
Leadership & Strategic Management
Team Oversight: Directly manage non-leadership employees and group leaders; handle scheduling, training, and fostering teamwork/morale.Operational Excellence: Ensure laboratory operations meet the highest quality, efficiency, and safety standards (including Health, Safety & Environmental responsibilities).Strategic Planning: Identify departmental unmet needs, focus on team time management, and implement LEAN projects or new technologies.Client Relations: Act as the primary technical contact for sponsors to coordinate studies and ensure expectations are met. Ability to sell potency service to clients.Technical Responsibilities
Method Development: Lead the development, qualification, and validation of cell-based analytical test methods for drug products and drug substances. Design studies to elucidate the cellular mode of action (MoA) of drugs and characterize drug-target interactions and signaling pathwaysAssay Execution: Perform tissue culture-based potency assays, ELISAs, and molecular biology techniques (qPCR, ddPCR, flow cytometry, DNA/RNA extraction/purification).Laboratory Support: Maintain multiple cell lines, prepare solutions/culture media, and utilize automation and advanced pipetting techniques.Technical Resource: Serve as the internal expert to resolve complex technical problems and oversee the onboarding of new instrumentation.Quality, Compliance & Documentation
Regulatory Oversight: Ensure strict adherence to GXP (GMP/GLP) compliance; interface with the FDA and other regulatory agencies as needed. Track record of developing and validating GMP methods to support drug commercialization.Scientific Review: Serve as the final reviewer for scientific rigor, conclusions, and the quality of reports sent to customers.Technical Writing: Author SOPs, policies, 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. Degree: Bachelor’s, Master’s, or Doctorate in Biology, Chemistry, Biochemistry, or a related physical sciences
Experience Levels:
Ph.D. with 10+ years of related industry experience.Master’s with 15+ years of related industry experience.Bachelor’s with 20+ years of related industry experience.Authorization: Must be authorized to work in the U.S. indefinitely without sponsorship.Essential Skills & Attributes
Communication: Exceptional 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. 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 $150,000 - $200,000 at a Director level depending on related experience.
Excellent full time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.