Associate Scientist, Analytical Sciences & Quality Testing (ASQT)
Kiniksa Pharmaceuticals
3 months ago
On-site
Lexington, MA
Operations
Responsibilities:
- Lead the development, qualification, and execution of robust analytical methods to ensure product quality and reliability.
- Execute analytical testing for GMP and non-GMP release and stability samples.
- Adhere to cGMP by completing and maintaining accurate cGMP documentation (electronic and hard copy).
- Support daily lab operations (reagent preparation, routine instrument calibration) and maintain reagent/material inventory.
- Support GMP data review and compliance checks (data scanning and trend analysis).
- Contribute to method qualification activities with internal teams and external contract testing labs.
- Author/revise/execute technical protocols, reports, test methods, and SOPs; assist with regulatory readiness.
- Coordinate sample management (shipment, receipt, log-in, inventory control).
- Help maintain a safe, organized, compliant laboratory environment by identifying and addressing safety hazards.
Qualifications & Experience:
- Bachelor’s degree in life sciences with 3+ years’ experience, or M.S. with 1+ year, in analytical development and QC in pharma/biotech.
- Experience in a GMP-regulated environment.
- Familiarity with LIMS and software such as SoloVPE (Viper), Empower, Compass, and SoftMax.
- Protein analytical techniques: SoloVPE, icIEF, CE-SDS, ELISA; HPLC-SEC, peptide mapping, and N-glycan analysis preferred.
Pay Range: $95,000 - $108,000 USD
On-site: 5 days/week in Lexington, MA. Reports to: Director, ASQT.
- Lead the development, qualification, and execution of robust analytical methods to ensure product quality and reliability.
- Execute analytical testing for GMP and non-GMP release and stability samples.
- Adhere to cGMP by completing and maintaining accurate cGMP documentation (electronic and hard copy).
- Support daily lab operations (reagent preparation, routine instrument calibration) and maintain reagent/material inventory.
- Support GMP data review and compliance checks (data scanning and trend analysis).
- Contribute to method qualification activities with internal teams and external contract testing labs.
- Author/revise/execute technical protocols, reports, test methods, and SOPs; assist with regulatory readiness.
- Coordinate sample management (shipment, receipt, log-in, inventory control).
- Help maintain a safe, organized, compliant laboratory environment by identifying and addressing safety hazards.
Qualifications & Experience:
- Bachelor’s degree in life sciences with 3+ years’ experience, or M.S. with 1+ year, in analytical development and QC in pharma/biotech.
- Experience in a GMP-regulated environment.
- Familiarity with LIMS and software such as SoloVPE (Viper), Empower, Compass, and SoftMax.
- Protein analytical techniques: SoloVPE, icIEF, CE-SDS, ELISA; HPLC-SEC, peptide mapping, and N-glycan analysis preferred.
Pay Range: $95,000 - $108,000 USD
On-site: 5 days/week in Lexington, MA. Reports to: Director, ASQT.