Job Description
Job Description
Duties:
- 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
- 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.
Qualifications:
- 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
- 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
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
- Medical insurance – PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval
Pay Scale:
$124,000 - $144,000 (Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.
The cornerstone of our success: a knowledgeable and experienced recruiting team.
Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.
Company Description
R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\r\n\r\nThe cornerstone of our success: a knowledgeable and experienced recruiting team.\r\n\r\nOur life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.