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

Manufacturing Science And Technology (MSAT) Role

The successful candidate will be responsible for Manufacturing Science and Technology (MSAT) activities for cell therapy products in our Type 1 Diabetes (T1D) program as well as our gene therapy (Casgevy) program. The candidate will provide 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 working in cross-functional environment.

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.

Preferred qualifications:

• 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. 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
• Knowledge of cGXP theory and practices is required.
• Ability to communicate effectively with a diverse range of scientists, engineers, regulatory specialists, and business professionals
• 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, as are 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.

Pay Range: $123,200 – $184,800

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation: On-Site Designated

Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.