Planet Pharma
Overview
QC Senior Research Associate at Planet Pharma.
Responsibilities
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.
Develop 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 equipment is calibrated.
Software & Methods
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
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 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 to bring novel medicines to the clinic.
Excellent organizational and communication skills.
Experience with JMP statistical software is a plus.
Education
BS or equivalent in a relevant discipline with a minimum of 2-5 years of relevant industry experience, or Master’s degree with a minimum of 0-1 years of relevant industry experience.
Compensation & Benefits Pay ranges between $58-68/hr based on experience. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Location San Diego, CA
Note: This posting may include additional related roles listed below.
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Responsibilities
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.
Develop 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 equipment is calibrated.
Software & Methods
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
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 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 to bring novel medicines to the clinic.
Excellent organizational and communication skills.
Experience with JMP statistical software is a plus.
Education
BS or equivalent in a relevant discipline with a minimum of 2-5 years of relevant industry experience, or Master’s degree with a minimum of 0-1 years of relevant industry experience.
Compensation & Benefits Pay ranges between $58-68/hr based on experience. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Location San Diego, CA
Note: This posting may include additional related roles listed below.
#J-18808-Ljbffr