QualificationsThe Ideal Candidate would possess:
- 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
Basic Minimum Requirements
- 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
- 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.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
- 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