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

Job Description

General Summary:

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 Masters degree with minimum 5 years of industry experience or Bachelors 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.

#LI-LE1

Pay Range:

Disclosure Statement:

Flex Designation:

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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

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 persons 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.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at