Job Description

Representative responsibilities will include, but not necessarily be limited to, the following: 

Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring and drug product release, specifically SDS-PAGE, western blot, droplet digital PCR or qPCR, culture of primary mammalian cells, and cell?based potency assays.
Participate in developing timelines, protocols and reports for assay transfers, qualifications / validations.
Contribute to establishing material specifications for drug substance and drug products
Author and review QC analytical SOPs, protocols, and reports as needed
Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports
May act as an analytical lab representative on a CMC team.
Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures.
Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibrated

Software Use Expectations:
Utilize the LIMS system to submit samples, enter data, and track samples
Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria
Learn and become proficient in all laboratory instrument software to conduct testing

Skills:    
Experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role
Experience in optimizing methods with particular emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assays
Significant experience in an FDA-regulated environment
Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
Excellent organizational and communication skills
Experience with JMP statistical software a plus

Education:    
BS or equivalent in relevant discipline with a minimum of 2-5 years of relevant industry experience or Master’s degree in relevant discipline with a minimum of 0-1 years of relevant industry experience

Pay ranges between $58-68/hr based on expereince 

Job Tags

Contract work,

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