Eurofins BioPharma Product Testing North America · 5 hours ago
Bioassay Associate Director
Eurofins Scientific is an international life sciences company providing analytical testing services across multiple industries. The Bioassay Associate Director will lead a team in managing laboratory operations, ensuring compliance with quality standards, and developing analytical test methods for drug products.
Biotechnology
Responsibilities
Directly manage non-leadership employees and group leaders; handle scheduling, training, and fostering teamwork/morale
Ensure laboratory operations meet the highest quality, efficiency, and safety standards (including Health, Safety & Environmental responsibilities)
Identify departmental unmet needs, focus on team time management, and implement LEAN projects or new technologies
Act as the primary technical contact for sponsors to coordinate studies and ensure expectations are met
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
Perform tissue culture-based potency assays, ELISAs, and molecular biology techniques (qPCR, ddPCR, flow cytometry, DNA/RNA extraction/purification)
Maintain multiple cell lines, prepare solutions/culture media, and utilize automation and advanced pipetting techniques
Serve as the internal expert to resolve complex technical problems and oversee the onboarding of new instrumentation
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
Serve as the final reviewer for scientific rigor, conclusions, and the quality of reports sent to customers
Author SOPs, policies, and procedures; maintain accurate records and ensure the integrity of all laboratory work
Take ownership of reporting errors, deviations, or Out of Specification (OOS) occurrences promptly
Qualification
Required
Bachelor's, Master's, or Doctorate in Biology, Chemistry, Biochemistry, or a related physical sciences
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
Exceptional oral and written communication skills for technical writing, client interaction, and professional peer engagement
Advanced proficiency in Excel (formulas and linking spreadsheets) and general scientific software
High attention to detail, self-motivated, adaptable, and willing to work overtime when necessary to meet group deadlines
Benefits
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
Company
Eurofins BioPharma Product Testing North America
Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies.
Funding
Current Stage
Late StageCompany data provided by crunchbase