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15 days old

Principle Scientist (Bioassay Development) - Fremont, CA

Kelly Services
Fremont, CA 94536
**Principle Scientist (Bioassay Development) - Fremont, CA**


**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 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 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 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


**Qualifications:**

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


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**_\#TJP2021_SPEC_**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-04-23 Expires: 2021-05-24

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Principle Scientist (Bioassay Development) - Fremont, CA

Kelly Services
Fremont, CA 94536

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