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:

$143,700 - $215,600

Disclosure Statement:

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.

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 stat