Eurofins BioPharma Product Testing North America
Bioassay Associate Director
Eurofins BioPharma Product Testing North America, San Diego, California, United States, 92189
4 days ago - Be among the first 25 applicants
Base pay range $150,000 – $180,000 per year.
Eurofins Scientific is an international life sciences company that provides a unique range of analytical testing services to clients across multiple industries, ensuring products are safe, authentic, and accurately labeled.
Job Description Leadership & Strategic Management
Team Oversight:
Directly manage non-leadership employees and group leaders; handle scheduling, training, and foster teamwork/morale.
Operational Excellence:
Ensure laboratory operations meet the highest quality, efficiency, and safety standards (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.
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 pathways.
Assay 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) incidences promptly.
Qualifications Degree:
Bachelor’s, Master’s, or Doctorate in Biology, Chemistry, Biochemistry, or related physical sciences.
Ph.D.:
10+ years of related experience.
Master’s:
15+ years of related experience.
Bachelor’s:
20+ years of related 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.
Additional Information Position is full‑time, first shift Monday–Friday 9:00 a.m.–5:00 p.m. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.
Benefits include comprehensive medical, dental, and vision coverage, 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.
Referrals Referrals increase your chances of interviewing at Eurofins BioPharma Product Testing North America by 2x.
#J-18808-Ljbffr
Base pay range $150,000 – $180,000 per year.
Eurofins Scientific is an international life sciences company that provides a unique range of analytical testing services to clients across multiple industries, ensuring products are safe, authentic, and accurately labeled.
Job Description Leadership & Strategic Management
Team Oversight:
Directly manage non-leadership employees and group leaders; handle scheduling, training, and foster teamwork/morale.
Operational Excellence:
Ensure laboratory operations meet the highest quality, efficiency, and safety standards (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.
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 pathways.
Assay 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) incidences promptly.
Qualifications Degree:
Bachelor’s, Master’s, or Doctorate in Biology, Chemistry, Biochemistry, or related physical sciences.
Ph.D.:
10+ years of related experience.
Master’s:
15+ years of related experience.
Bachelor’s:
20+ years of related 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.
Additional Information Position is full‑time, first shift Monday–Friday 9:00 a.m.–5:00 p.m. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.
Benefits include comprehensive medical, dental, and vision coverage, 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.
Referrals Referrals increase your chances of interviewing at Eurofins BioPharma Product Testing North America by 2x.
#J-18808-Ljbffr