Senior QC Analytical Scientist | GMP & Validation

Astellas; Westborough (MA); On-site; USD 119,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Paid Time Off

401(k) match and company contributions

Annual Corporate Bonus

Long Term Incentive Plan

Job summary

Astellas is seeking a Principal Scientist, Analytical, Quality Control in Westborough, MA. This role supports QC Analytical operations, ensures data integrity, leads method qualifications and CAPA-driven investigations, and collaborates across functions to advance commercial readiness in a cGMP environment.

The successful candidate will drive technology evaluations, support regulatory filings and inspections, and contribute to continuous improvement of analytical workflows.

Qualifications

• PhD/MS/BS in Cell Biology or equivalent.
• 6+ years (PhD) / 8+ years (MS) / 10+ years (BS) of QC or related pharma experience.
• Strong experience in developing, optimizing, qualifying and validating analytical cell-based assays.

Responsibilities

• Ensure data integrity for QC Analytical laboratory data and support QC equipment validation, maintenance, and calibration.
• Perform routine in-process and release QC testing of cell products.
• Oversee analytical method qualifications, validations and transfers including drafting protocols and reports.

Skills

Data integrity

Analytical method validation

cGMP knowledge

Regulatory guidance knowledge (ICH/FDA

Leadership & project management

Communication & problem solving

Education

PhD in Cell Biology or related

MS in Life Sciences

BS in Life Sciences

Tools

LIMS

Job description

Astellas is seeking a Principal Scientist, Analytical, Quality Control in Westborough, MA. This role supports QC Analytical operations, ensures data integrity, leads method qualifications and CAPA-driven investigations, and collaborates across functions to advance commercial readiness in a cGMP environment.

The successful candidate will drive technology evaluations, support regulatory filings and inspections, and contribute to continuous improvement of analytical workflows.