MSAT Scientist

$90,000 - $135,000/Yr

Actalent - Boston, MA

Full-time - Senior

Boston, MA

Administrative and Support Services

About the position

The MSAT Scientist position at Actalent involves providing direct oversight for GMP manufacturing of gene therapy products at external manufacturing partners. The role requires strong expertise in applied manufacturing sciences and technical project management to ensure quality compliance and effective coordination among various internal and external stakeholders.

Responsibilities

• Provide direct GMP manufacturing oversight for gene therapy products at external manufacturing partners.
• Act as a manufacturing Subject Matter Expert (SME) for clinical manufacturing processes, providing on-site support during critical operations.
• Drive GMP compliance and evaluate ongoing production, intervening and escalating issues as necessary.
• Collaborate with CDMO and internal teams to support manufacturing investigations and change controls.
• Review and approve CDMO manufacturing documentation, including master batch records and production records.
• Communicate production status to stakeholders and assist with data retrieval and analysis.
• Author key technical documentation supporting manufacturing activities and regulatory submissions.

Requirements

• Bachelor's degree in science or equivalent.
• 5+ years of experience in a related pharmaceutical environment.
• Strong knowledge of cGMP, GDP, GCP, and ICH guidelines.
• Demonstrated experience managing projects in the pharmaceutical industry.
• General knowledge of process development and pharmaceutical manufacturing for biologics.

Nice-to-haves

• Strong analytical skills.
• Ability to work in new/unstructured environments.
• Experience working with contract manufacturing organizations.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401(k)
• 401(k) matching
• Paid time off