Bioassay Associate Director

Eurofins BioPharma Product Testing North America; San Diego (CA); On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental and vision options

401(k) with company match

Paid vacation and holidays

Job summary

A leading bio-pharmaceutical testing laboratory in San Diego is seeking a professional to oversee laboratory operations while ensuring the highest quality and safety standards. The role involves managing staff, developing analytical methods, and ensuring compliance with regulatory standards like GXP. Ideal candidates have advanced degrees in biological sciences and significant related experience. This full-time position offers a competitive salary and comprehensive benefits.

Qualifications

• Ph.D. with 10+ years of related experience.
• Master’s with 15+ years of related experience.
• Bachelor’s with 20+ years of related experience.
• Must be authorized to work in the U.S. indefinitely without sponsorship.

Responsibilities

• Directly manage non-leadership employees and group leaders.
• Ensure laboratory operations meet the highest quality and safety standards.
• Lead the development of analytical test methods.
• Ensure compliance with GXP regulations and interface with the FDA.

Skills

Exceptional oral and written communication

Advanced proficiency in Excel

High attention to detail

Education

Bachelor’s, Master’s, or Doctorate in Biology, Chemistry, or Biochemistry

Job description

Overview

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

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.

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) occurrences promptly.

Qualifications

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 experience.
• Master’s with 15+ years of related experience.
• Bachelor’s with 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 9:00am - 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 - $180,000 at a Associate Director or Director level 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.