BostonRecruiter Since 2001
the smart solution for Boston jobs

Sr. Director, Manufacturing Operations Viral Vectors

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treatand even cureseveral of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertexs continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. Vertex, a biopharmaceutical company focused on developing a cell and gene-based therapies for multiple indications, is seeking a Senior Director of Viral Vector Manufacturing Operations to join its growing team. The full-time role will be responsible for oversight of Vertexs viral vector materials production facility and will oversee the efforts of the Manufacturing and Process Development staff. The Senior Director of Viral Vector Manufacturing Operations will work closely with the executive team, supply chain, delivery device, preclinical, and quality teams to meet program milestones. The position will be based in Boston, MA. Key Responsibilities :

* Identify, test, develop, qualify and implement technologies required to support viral vector manufacturing through oversight of Process Development Team * Work independently and with the team to develop an integrated CMC operations plan from current stage through to product launch * 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 * Ensure safe and compliant clinical manufacturing operations by leading the operations management team providing support to execution * Coordinate and integrate the activities of various departments to ensure alignment in scope, schedule and budget. Ensure resources are being utilized on the most impactful activities. * Ensure timely completion of activities needed for the Investigational New Drug (IND) application with the US Food and Drug Administration (FDA). Supports the filing activities as needed. * Partner with QA to develop and implement phase-appropriate Quality Systems for operations * Provide and confirm user input is used for the design and commissioning of the manufacturing facility and equipment * Lead design and start-up activities for new manufacturing site * Identify possible 3rd part CDMO for expansion of capacity * Tech transfer production technologies to third party vendors are required. * Build and develop a high-performing manufacturing team, including operations management, ensuring the right skills are added at the appropriate time during periods of rapid growth. * Provide business case justification to obtain buy-in from senior stakeholders to secure required operational resources and manufacturing capacity * Set clear objectives, monitor and report on performance of the Operations team in key areas including Quality, Safety, Delivery, and People. Mitigate and escalate risks to the appropriate level * Oversee the performance, quality and delivery of external supply partners * Develop operation's strategy to take Vertex's products to commercial production quickly and safely * Foster an inclusive, collaborative, transparent, engaged and accountable culture. Coach team for positive inter-departmental collaboration * Responsible for establishing the budget and maintaining control of costs * Drive continuous improvement activities and operational excellence, including reduction of Cost of Goods Sold (COGS) and commercial readiness * Represents manufacturing operations to senior management and external organizations and agencies

Minimal Requirements :

* PhD in Life Sciences, bio-engineering, or related discipline with minimum 15 years relevant work experience * 5+ years of demonstrated project management and change management experience in a pharmaceutical setting working with interdisciplinary and cross-cultural teams * Prior experience working with viral vector design, manufacturing and qualification technologies * Strong analytical skills, focused with business awareness and hands on to navigate execution in a highly matrixed environment * Ability to communicate effectively with a diverse range of scientists, physicians, engineers, regulatory specialists and business professionals * Experience providing clear leadership and orchestrating changes in a complex and fast-paced environment with competing priorities

Preferred Requirements:

* Experience in molecular or gene therapy product development (AAV Vector development) * Experience in manufacturing facility management * Gene Therapy Regulatory Affairs experience

#LI-BS1

Keywords: Vertex Pharmaceuticals Inc (US), Boston , Sr. Director, Manufacturing Operations Viral Vectors, Executive , Boston, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Branch Manager (Float) Boston, MA
Description: Branch Manager Float Boston, MA-----2003049--Description-- POSITION SUMMARY The Manager, Branch Manager is responsible for the administration of sales, service, operational efficiency, risk applications, (more...)
Company: Santander Holdings USA Inc
Location: West Bridgewater
Posted on: 09/26/2020

Director, Inpatient Services
Description: DEPARTMENT DESCRIPTION: Beth Israel Deaconess Hospital-Needham BID Needham is a licensed 58 bed acute care hospital offering the same care as our direct affiliate Beth Israel Deaconess Medical Center (more...)
Company: Beth Israel Deaconess Medical Center
Location: Needham
Posted on: 09/26/2020

Manager, CFO Services
Description: Alvarez Marsal Private Equity Performance ImprovementManager: CFO ServicesAlvarez Marsal, a leading independent global professional services firm, specializing in providing turnaround management, (more...)
Company: Alvarez & Marsal
Location: Boston
Posted on: 09/26/2020


Senior IT Security Engineer / Manager
Description: Our client is seeking a hands-on Senior IT Security Engineer Manager with 8 yrs of experience. There will be some on-site and remote to start. Responsibilities In depth knowledge of TCPIP, switches, routers, (more...)
Company: Stone Search
Location: Marlborough
Posted on: 09/26/2020

General Manager Designate
Description: We're looking for a candidate to fill this position in an exciting company. ul li Manage a market center location annual revenue of 10M li Drive profitability and growth by obtaining
Company: AmeriPride Services Inc.
Location: Boston
Posted on: 09/26/2020

Data Analyst (PBM-Pharmacy benefit management Exp)
Description: Title Data Analyst PBM-Pharmacy benefit management Exp Location Boston, MA Duration Long-Term Job Description We are looking for an experienced Data Analyst with healthcare
Company: Kaizen Technologies
Location: Boston
Posted on: 09/26/2020

Branch Manager (Float) Boston, MA
Description: Branch Manager Float Boston, MA-----2003049--Description-- POSITION SUMMARY The Manager, Branch Manager is responsible for the administration of sales, service, operational efficiency, risk applications, (more...)
Company: Santander Holdings USA Inc
Location: Boston
Posted on: 09/26/2020

Manager, Clinical Care Partnership
Description: MANAGER, CLINICAL CARE PARTNERSHIP br br Job ID br br 2020-3443 br br Category br br Clinical Office Based br br Type br br Regular Full-Time br br Actual Work Location (more...)
Company: Commonwealth Care Alliance
Location: Charlestown
Posted on: 09/26/2020

Agile Project Manager - PMP, Bachelor Degree
Description: Please contact Abdul on 510.623.5049 OR email me at The ideal candidate will have several years of experience in Agile methodologies and the change management processes inherent in driving a company (more...)
Company: APN Software Services, Inc
Location: Norwood
Posted on: 09/26/2020

Regional Property Manager Affordable Housing
Description: Our client is a prominent real estate investment, development and property management firm seeking a Regional Property Manager to join their Affordable Housing team in Massachusetts.Salary/Hourly Rate: (more...)
Company: Atrium Staffing
Location: Boston
Posted on: 09/26/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds