Senior Manager, Manufacturing Technical Operations

Job Description

General Summary:

The Sr. Manager, Manufacturing Technical Operations (MTO) is responsible for managing compliance related Quality records including, but not limited to, deviations, corrective and preventive action (CAPA), change controls, risk assessments and analytical investigations supporting Biopharma Cell and Gene Therapy (CGT) in Boston. This includes all aspects of quality event ownership and support from triage through root cause investigation through completion. This role will establish and promote MTO/QA aligned best-practices for compliance to ensure on-time and thorough completion. This role is an on-site, 1st shift position in our Boston location. This role will require ad-hoc flexibility (nights, weekends) to support our cell manufacturing needs.

Key Duties and Responsibilities:

• Triage manufacturing and QC issues that occur during operations; collaborate with cross-functional team for containment, impact and initiate investigation
• Lead cross functional investigations for deviations to determine root cause and present findings and recommendations to CMC leadership team for alignment subsequent draft and manage appropriate CAPAs.
• Promote MTO best practices to further establish quality event record center of excellence teams.
• Own and drive change controls, risk assessments, document revisions with cross-functional team including process development, manufacturing, quality control, quality assurance, regulatory.
• Monitor quality event metrics across CGT, escalate issues, propose improvements, and deploy MTO resources to support event closure.
• Maintain compliance with company policy and regulatory guidance.
• Provide continuous support to all stakeholders to ensure successful product release.
• Support inspections and audits with regulatory agencies.
• Demonstrate the Vertex behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
• Other duties and projects as assigned to meet departmental requirements.

Minimum Qualifications:

• 10+ years progressive experience in pharmaceutical development/manufacturing.
• 4+ years of experience mentoring and managing staff.
• Understanding of science and technology of GMP cell and gene manufacturing environment.
• Experience aseptic gowning and working in Grade B cleanroom environment
• Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
• Expert level proficiency with technical writing and superb verbal and written communication skills.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

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 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.

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 ApplicationAssistance@vrtx.com