Process Engineer II, Biotech GMP & Tech Transfer

Genetix Biotherapeutics; Boston (MA); Hybrid; USD 90,000 - 116,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Health, life and disability insurance

Employer‑matched 401(k)

Paid holidays and winter break

Tuition reimbursement & loan repayment

Paid parental leave

Paid onsite parking

Commuter subsidy

Job summary

Genetix Biotherapeutics is seeking a Process Engineer II to join the MSAT team in our hybrid role based in Somerville, MA. You will support technology transfer and ongoing commercial production across CDMO partnerships, ensuring cGMP compliance and robust process control.

You will lead cross-functional teams, analyze data with statistical tools, and drive improvement initiatives to enhance process performance and product quality in a dynamic biopharma manufacturing environment.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field.
• 3–5 years in biopharma manufacturing/MSAT/CMC roles; cell/gene therapy or biologics preferred.
• Experience in a cGMP manufacturing environment with focus on tech transfer.
• Strong knowledge of manufacturing processes, RCA, and corrective action planning.
• Excellent communication and leadership; able to coordinate cross-functional teams.

Responsibilities

• Act as the primary technical expert for GMP production at CDMO partners.
• Conduct complex manufacturing investigations using root cause analysis to prevent recurrence.
• Develop and maintain process trending and continued process verification programs.
• Drive continuous improvement and operational excellence to enhance process performance.
• Lead cross-functional tech transfer teams and coordinate progress across workstreams.
• Prepare and review process descriptions, sampling plans, training materials, risk assessments, and reports.
• Apply statistical tools for data analysis to understand variability and resolve issues.
• Provide hands-on support for tech transfer and GMP runs as PiP.
• Oversee PPQ runs and ensure successful qualification of processes.

Skills

Technical problem-solving

Autologous cell therapies

Regulatory knowledge

Cross-functional leadership

Education

Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field

Job description

Genetix Biotherapeutics is seeking a Process Engineer II to join the MSAT team in our hybrid role based in Somerville, MA. You will support technology transfer and ongoing commercial production across CDMO partnerships, ensuring cGMP compliance and robust process control.

You will lead cross-functional teams, analyze data with statistical tools, and drive improvement initiatives to enhance process performance and product quality in a dynamic biopharma manufacturing environment.