Process Development Engineering Senior Scientist (MSAT), Cell and Gene Therapy

Vertex Inc. • Boston, MA

7d • Onsite

About The Position

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency. Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. The successful candidate for the Process Development Engineering Senior Scientist (MSAT), Cell and Gene Therapy role will be responsible for Manufacturing Science and Technology (MSAT) activities for cell therapy products in the Type 1 Diabetes (T1D) program as well as the gene therapy (Casgevy) program. This role involves providing cross-functional leadership in technology development and transfer from Development to Clinical Manufacturing and Process Performance Qualification, including internal operations and potentially various CDMOs. The candidate will also plan and implement continuous improvement initiatives for life-cycle management within a cross-functional environment.

Requirements

• PhD in Life Sciences, chemical engineering, or related discipline with minimum 2+ years of relevant industrial work experience or Master’s degree with minimum 5+ years of industry experience or Bachelor's degree with 8+ years of relevant industry experience.
• Hands on experience with Manufacturing Science and Technology (MSAT) investigation and change management.
• Knowledge of cGXP theory and practices is required.
• Proven experience with MSAT, Process Technology Transfer, Technical Operations, and Lifecycle Management.
• Knowledge of Design Control and Risk Management, including experience using FMEA analyses.
• A strong understanding of statistical analyses is required.
• Strong technical writing and presentation skills.
• Must be able to work independently with adequate supervision and support in parallel a few projects.
• Must demonstrate strong interpersonal and teamwork skills, with experience managing and training team.
• Ability to communicate effectively with a diverse range of scientists, engineers, regulatory specialists, and business professionals

Nice To Haves

• Experience with cell-gene therapy is preferred.
• Hands on experience with regulatory filings is preferred.
• Experience working with cell processing, specifically with primary cells.
• Experience with cell therapy products is preferred.

Responsibilities

• Lead triage, investigation, and change control implementation as a Manufacturing Science and Technology functional area assessor and identify improvements, implement changes, and monitor clinical and commercial manufacturing processes.
• Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines.
• Minimize timeline deviations by clearly identifying program risks and communication of strategies
• Review and contribute to regulatory submissions (IND, IMPD).
• Author supporting documents and reports.
• Coordinate and integrate cross-functional activities to ensure alignment in scope, schedule and budget
• Drive continuous improvement activities and operational excellence, including COGS reduction and commercial readiness.
• Champion pre-PPQ and PPQ activities.
• Establish robust process performance across all clinical and commercial manufacturing lines, including process development, process improvement, and maintenance of process excellence.
• Lead process monitoring, continuous improvement, and lifecycle management initiatives guided by risk assessment and mitigation strategies
• Oversee CDMOs activities by providing guidance and support in collaborative manner.
• Be responsible for the performance, quality and delivery of external collaborators
• Collaborate within departmental teams, actively contribute to deliverables and engage in team discussion on issue resolution.

Benefits

• Annual bonus
• Annual equity awards
• Overtime pay (for some roles, in accordance with federal and state requirements)
• Inclusive market-leading benefits
• Medical benefits
• Dental benefits
• Vision benefits
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• Educational assistance programs including student loan repayment
• Generous commuting subsidy
• Matching charitable donations
• 401(k)
• Flex @ Vertex Program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree