Description
\t\t\t\t\tReview protocols, testing, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, ddPCR, in-vitro based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot) generated at CTLs/CMOsAnalytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagentsSupport the method development, transfer and qualification/validation activities associated with the release of bacterial plasmids, viral vector products, critical reagents and reference material. Trend data for qualified materials, release products, and stability products. Assist in writing and reviewing quality documents such as SOP, OOS/OOT, CAPA and Change ControlCompany liaison with CMOs to coordinate in method development, method transfer, and release and stability testing across various CMO/CRO sites
\t\t\t\t\tSkills
\t\t\t\t\tquality control, stability testing, elisa, SDS page, HPLC, Western Blot, pcr, ddpcr, Data review, CMO, capa, change control, CDMO
\t\t\t\t\tTop Skills Details
\t\t\t\t\tquality control,stability testing,elisa,SDS page,HPLC,Western Blot,pcr,ddpcr,Data review
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\tB.S. or M.S. degree in molecular biology, cell biology or virology with at least 2-5 years relevant experience. Working experience in a cGMP environment is preferred. A strong understanding of cell culture methods, polymerase chain reaction (PCR,) agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays. A familiarity with compendial (USP, ICH, EP) guidance is highly desired. Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary. Experience in developing, validating, and deploying molecular biology test methods is useful
\t\t\t\t\tExperience Level
\t\t\t\t\tIntermediate Level
Pay and Benefits
The pay range for this position is $50.00 - $56.00
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Andover,MA.
Application Deadline
This position will be accepting applications until Dec 30, 2024.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.