Vertex Pharmaceuticals
Manufacturing Technical Operations Manager
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Job DescriptionThe Manager for Manufacturing Technical Operations (MTO) is responsible for the leadership of the Technical Operations Team supporting Cell and Gene Therapy (CGT) cell manufacturing operations at Boston Seaport location. The Manager is responsible for the immediate triage, investigation, cross-functional collaboration, of manufacturing and cross functional deviations. The Manager will be pivotal for maintaining quality event management and inspection readiness. This role aims to support our growing team in conducting root cause analyses, driving impact and risk assessments and formulating corrective and preventive actions (CAPAs) throughout VCGT. This role is an on-site position in our Boston location in Seaport with occasional travel to Cambridge required.The Manager will work one of the following shifts:Sunday - Wednesday 1st shift (9:00 am - 7:30 pm)Thursday - Saturday 1st shift (9:00 am - 7:30 pm)KEY
RESPONSIBILITIES:Lead, write and review deviations and investigations for Drug Substance / Drug Product Manufacturing, Facilities, Supply Chain and Material Operations.Manage team of approximately 5 extended workforce membersLead cross functional investigations to determine root cause for deviations and analytical investigations.Identify and collaborate with SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, and develop appropriate CAPAs.Own and drive deviations, CAPA, Analytical Investigations (AI) and change control records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.Lead cross functional meetings and regularly update stakeholders on the status of ongoing investigations, ensuring transparent communication and timely resolution.Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.Collaborates with subject matter experts to perform risk-based impact assessments.Provide continuous support to all stakeholders to ensure successful release and complete oversight of related quality events.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:4+ years progressive experience in pharmaceutical development and manufacturing.2+ years of experience mentoring and managing staff.Understanding of the science and technology of cell and gene therapies.Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.Excel in interpersonal relations, showcasing ability to lead through influence and effectively lead high performing teams.Experienced with technical writing and performing event investigations in a GMP-compliant environment.#LI-onsite #LI-SVFlex 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 InformationVertex 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
RESPONSIBILITIES:Lead, write and review deviations and investigations for Drug Substance / Drug Product Manufacturing, Facilities, Supply Chain and Material Operations.Manage team of approximately 5 extended workforce membersLead cross functional investigations to determine root cause for deviations and analytical investigations.Identify and collaborate with SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, and develop appropriate CAPAs.Own and drive deviations, CAPA, Analytical Investigations (AI) and change control records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.Lead cross functional meetings and regularly update stakeholders on the status of ongoing investigations, ensuring transparent communication and timely resolution.Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.Collaborates with subject matter experts to perform risk-based impact assessments.Provide continuous support to all stakeholders to ensure successful release and complete oversight of related quality events.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:4+ years progressive experience in pharmaceutical development and manufacturing.2+ years of experience mentoring and managing staff.Understanding of the science and technology of cell and gene therapies.Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.Excel in interpersonal relations, showcasing ability to lead through influence and effectively lead high performing teams.Experienced with technical writing and performing event investigations in a GMP-compliant environment.#LI-onsite #LI-SVFlex 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 InformationVertex 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