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Principal Scientist - Bioassay Development

Eurofins Lancaster Laboratories
Fremont, CA
Closing date
Oct 31, 2021

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Job Description
  • 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
QualificationsThe 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
Additional InformationCandidates 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.
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