Senior QC Lead, Internal Ops - GMP & Gene Therapy

BioSpace; Boston (MA); On-site; USD 71,250 - 161,700; Full time

Benefits offered by this job

401(k) plan

Healthcare benefits

Bonus eligibility

Flexible benefits

Fitness benefits

Job summary

A biotech company in Boston is seeking a Senior Associate in Quality Control. This position involves performing potency testing in compliance with GMP standards. The ideal candidate will have a Bachelor’s degree and at least 3 years of experience in the pharmaceutical industry. Responsibilities include reviewing analytical data, managing laboratory projects, and ensuring adherence to regulatory requirements. The expected compensation ranges from $71,250 to $161,700, and the role requires on-site presence in our Boston lab.

Qualifications

• 3+ years in the pharmaceutical or biopharmaceutical industry.
• Experience in gene therapy product testing is preferred.
• Understanding of FDA CFR and GMP regulations.

Responsibilities

• Perform routine potency testing for drug substances.
• Review cGMP analytical data from various test methods.
• Manage projects involving implementation of tech transfer.

Skills

Potency testing

Data integrity principles

Problem solving

Communication skills

GMP environment experience

Education

Bachelor’s degree in chemistry or related area

Tools

Veeva LIMS

Microsoft Word

Microsoft Excel

Job description

A biotech company in Boston is seeking a Senior Associate in Quality Control. This position involves performing potency testing in compliance with GMP standards. The ideal candidate will have a Bachelor’s degree and at least 3 years of experience in the pharmaceutical industry. Responsibilities include reviewing analytical data, managing laboratory projects, and ensuring adherence to regulatory requirements. The expected compensation ranges from $71,250 to $161,700, and the role requires on-site presence in our Boston lab.