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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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 Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers 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 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.
* Responsible for leading method development, optimization, and phase-appropriate qualification of custom bioassays for clients per ICH guidelines, meeting defined project timelines and producing high quality data and reports
* Participates in intake phone calls with new clients to establish project requirements and deliverables, and teleconferences with clients to communicate progress of on-going projects
* Oversees development, troubleshooting, and qualification of new bioassays in product portfolio intended for potency / lot release or neutralizing antibody (NAb) applications.
* Implements design of experiment (DoE) approaches in bioassay development and qualification process to understand performance characteristics and improve robustness of DiscoverX bioassays
* Writes detailed methods to facilitate assay transfer and documents critical manufacturing information in the development of ready-to-use cell banks and transfers to Cell Manufacturing team
* Serve as liaison between the Bioassay, Cell Manufacturing, Customer support and Marketing teams to ensure successful implementation of DiscoverX bioassays at customer sites
* Prepares and collaborates with QA and Marketing in finalizing all appropriate documentation (SOPs, user manuals, qualification reports, etc.) to support product launch or transfer of assays / methods to client sites
* Participates in method transfer phone calls with clients, and training of DiscoverX technical support staff who will be responsible for training employees at client sites to transfer methods
* Prepares data and scientific content for presentations, posters, webinars, manuscripts, white papers, or other relevant company materials
* Demonstrates and promotes the company vision
* Conducts all activities in a safe and efficient manner
* Performs other duties as assigned
* Owns the accountability and responsibility of delivering to client needs and timelines
* Provides cross-functional support to other departments as required
* Adjusts work hours as needed to meet client deadlines
* Adheres to site employee health and safety (EHS) requirements
The Ideal Candidate would possess:
* Experience in GMP/GLP environment strongly preferred.
* Demonstrated knowledge of ICH guidelines for bioassay method development/qualification and validation required.
* Experience dealing directly with clients in industry setting (e.g. CRO/client relationship).
* Experience with design of experiment (DoE) in bioassay development
* Experience developing cell-based assays for neutralizing antibody detection
* Effective oral presentation skills and comfort with public speaking
Basic Minimum Requirements:
* MS/PhD or equivalent experience in cell biology, biochemistry or related discipline, with a minimum of 5 years of industrial experience in Bioassay development, or method qualification/validation.
* Prior hands-on experience using cell based assays for protein /antibody characterization and release testing
* Experience in method development, qualification, and/or validation and transfer of bioassays utilized in lot release and stability testing required
* Experience using PLA, Softmax Pro, JMP or a related software package for analyzing data from potency assays is essential
* Experience drafting qualification or validation reports, or SOPs for assay transfer to CRO/CMO partners strongly preferred
* Excellent verbal, written communication and presentation skills are essential
* The successful candidate must be a highly motivated individual with a positive attitude who is comfortable multi-tasking in a fast-paced environment with defined deliverables and deadlines
* Ability to learn new techniques, solve practical problems and troubleshoot assays
* Must be team-oriented with a demonstrated track record working in a collaborative environment
* Authorization to work in the United States indefinitely without restriction or sponsorship
Candidates currently living within a commutable distance of Fremont, CA are encouraged to apply.
* 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.