Job Title: Senior Research Associate I

Duration: 05 Months (Possibility of hire)

Location: Marlborough, MA, 01752

Shift: 9-5 pm (with up to two weekends)

Minimum pay rate Starts from $32/hr on W2 (Negotiable)

Job Responsibilities:

• This position provides Quality Control testing of in process and final product testing. Looking for experience with cell culture, RT-qPCR, Immunofluorescence, cell based assays etc.
• Perform routine in-process and release QC testing of cell products.
• Execute analytical method validations and transfers including drafting technical protocols, reports and troubleshooting.
• Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
• Track and test products according to stability protocols. 5) Work with internal and external resources to maintain lab in an optimal state.
• Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
• Develop, revise and review SOPs, qualification/validation protocols and reports.
• Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.
• Monitor the GMP systems currently in place to ensure compliance with documented policies. Perform other lab duties as required.

Top 3-5 must have skills, years of experience:

• Cell culture of human cells ( not CHO or yeast or bacteria), GMP work experience. And anyone of the following ddPCR, flow cytometry, ASCP certification with QCYM.
• 2-4 years of experience

Education/ Experience:

• Bachelor or Master's degree in biotechnology or related field with 5+ years of Quality Control experience.
• Knowledge of GMP, SOP's and quality control process
• Experience in the biotech and/or pharmaceutical industry.
• Ability to work weekends.