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GForce Life Sciences

Analytical Scientist, Biologics, Consultant

GForce Life Sciences, Trenton, New Jersey, United States

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Analytical Scientist, Biologics, Consultant

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$55.00/hr - $64.00/hr Summary Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Scientist Consultant (QC/AS) to support the client studies of developmental, clinical, and commercial pharmaceutical and related products Duties / Expectations of Role Support analytical activities for late-stage biologics candidates. Work with CROs/CDMOs to coordinate analytical testing. Author/review analytical methods/protocols. Support method transfers to CROs/CDMOs. Evaluate analytical method validations. Interface with regulatory team to support authoring/review of analytical BLA sections and information requests from agencies. Provide deep expertise in potency assays including Cell Based Assays. Basic Qualifications Bachelor’s degree in Biochemistry, Molecular Biology, or similar scientific field and 8 years of industry experience. Master’s degree in Biochemistry, Molecular Biology, or similar scientific field and 6 years of industry experience. Ph.D. in Biochemistry, Molecular Biology, or similar scientific field and 4 years of industry experience. Preferred Qualifications Expertise in potency assays for biologics, especially Cell Based Assays. Basic understanding of other common biologics analytical techniques. Experience working with CDMOs and CROs including method transfers, and method development. Experience overseeing many concurrent studies at multiple distinct labs. Working knowledge of method validation principles. Experience with US and international BLA filings and reviews. Solid understanding of mAbs and other biologics, their attributes, and the appropriate tests for those attributes. Ability to distill and communicate complex analytical methods to non-experts. Term & Start 12 month contract, open to 12+ month extension 2 Video Interviews - Start 2 weeks from an offer Paid federal holidays Full time, 40 hours/week – benefits available (health, dental, vision, 401k) Remote – must work EST hours Seniority level

Mid-Senior level Employment type

Contract Job function

Science, Quality Assurance, and Research Pharmaceutical Manufacturing, Biotechnology Research, and Research Services Referrals increase your chances of interviewing at GForce Life Sciences by 2x Inferred from the description for this job

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