Process Engineer II

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Role Summary:
As a Process Engineer II in the Manufacturing Sciences and Technology (MSAT) team at Genetix, you will play a pivotal role in ensuring the seamless technology transfer and technical support of our platform in cGMP manufacturing. This position focuses on supporting ongoing commercial production, execution of projects within the CMC lifecycle and tech transfer. You will collaborate closely with Technical Development, Quality, and our CDMO (Contract Development and Manufacturing Organization) partners to guarantee that all aspects of technology transfer and technical support are executed effectively.

Key Responsibilities:

• Act as the primary technical expert for supporting the GMP production of autologous cell therapies at our CDMO partners.
• Conduct complex manufacturing investigations using root cause analysis tools to determine underlying causes and develop corrective and preventive actions to prevent recurrence.
• Develop and maintain process trending and continued process verification programs to ensure processes remain in a controlled state.
• Drive a culture of continuous improvement and operational excellence through the identification and execution of key projects that enhance process performance.
• Serve as a core team leader for cross-functional tech transfer teams, coordinating and tracking program progress within various workstreams.
• Prepare and review technical documentation including process descriptions, sampling plans, process training materials, risk assessments, study protocols, and technical reports.
• Utilize scientifically sound reasoning and statistical tools for data analysis, contributing to a deeper understanding of processes, identifying sources of variability, and resolving product and process failures.
• Provide hands-on support for tech transfer and GMP runs, serving as the lead Person in Plant (PiP).
• Oversee engineering and process performance qualification (PPQ) runs through successful completion.
• Exhibit a positive attitude and a proactive approach to problem-solving, embracing challenges with enthusiam and a solutions-oriented mindset.

Qualifications:

Education & Experience

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
• 3-5 years of experience in biopharma manufacturing, MS&T, or CMC roles; experience with drug product operations in cell and gene therapy or biologics preferred.
• Experience in a cGMP manufacturing environment, with a focus on technology transfer and process support.
• Strong knowledge of manufacturing processes, root cause analysis, and corrective action planning.
• Proficiency in project management tools and techniques.
• Excellent communication and leadership skills, with the ability to coordinate cross-functional teams and manage relationships with CDMO partners.
• Experience with statistical analysis and process trending programs.
• Ability to work independently and collaboratively in a dynamic environment.
• Demonstrated positive attitude and enthusiasm for problem-solving and overcoming challenges.

Skills & Competencies

• Strong technical problem-solving and analytical skills.
• Experience with autologous cell therapies or similar biopharmaceutical products.
• Familiarity with regulatory requirements and compliance standards in the biotechnology industry.
• Proven track record of driving process improvements and managing complex projects.