Job Title: Quality Control Scientist

Location: Marlborough, MA 01752

Duration: 06 Months

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.

Top Skills:

Cell culture of human cells ( not CHO, yeast, or bacteria), GMP work experience.

And anyone of the following ddPCR, flow cytometry, ASCP certification with QCYM.

Candidates from blood bank, cell therapy exp preferred.

Duties:

1) Perform routine in-process and release QC testing of cell products.

2) Execute analytical method validations and transfers including drafting technical protocols, reports and troubleshooting.

3) Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.

4) Track and test products according to stability protocols.

5) Work with internal and external resources to maintain lab in an optimal state.

6) Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.

7) Develop, revise and review SOPs, qualification/validation protocols and reports.

8) Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.

9) Monitor the GMP systems currently in place to ensure compliance with documented policies. Perform other lab duties as required.

REQUIRED:

1) Bachelor's or Master’s degree in biotechnology or related field with 5+ years of Quality Control experience.

2) Knowledge of GMP, SOP's and quality control process

3) Experience in the biotech and/or pharmaceutical industry.

4) Ability to work weekends.