Job Description

Vertex's Biopharmaceutical Sciences and Manufacturing Operations (BSMO) organization brings together the best biology, technologies, and enhanced manufacturing capabilities to bring cutting-edge, transformative cell and gene therapies (CGT) to patients as quickly as possible. The Senior Manager, Manufacturing Engineering will be responsible for designing for manufacturability, tech transfer, troubleshooting and manufacturing equipment of cell therapy and combination products, from clinical to early commercial manufacturing for our growing Type 1 Diabetes (T1D) program. This leader will build and manage a newly-formed manufacturing engineering team. The Senior Manager, Manufacturing Engineering will collaborate closely with process development and other CMC stakeholders to set strategic directions and ensure successful project outcomes. Additionally, this leader will represent the manufacturing organization on cross-functional teams throughout Vertex.

The Senior Manager, Manufacturing Engineering for Drug Substance Drug Product (DSDP) CMC Manufacturing will be a strategic leader building and overseeing a new organization to oversee Vertex's first of its kind cell therapy combination product, foreseeing the launch of GMP Manufacturing Phase III (Pivotal) and Commercial stage gates. The role reports to the Director of Manufacturing Operations, DSDP Type 1 Diabetes (T1D) program. The position is key to GMP manufacturing of current and new generations of cell and combination products and should possess prior knowledge of the US-FDA, EU and UK Medical Device regulations in addition to GMP cell manufacturing experience.

This position will partner with cross-functional stakeholders to lead MFG in technical transfer activities within Vertex internal Process Development, Quality, Validation, Supply chain, MFG sites and/or to external Contract Manufacturing Organization in support of developing operationally fit manufacture of cell and cell/device combination products for Cell & Genetic Therapy. The role will be responsible for inspiring/building/promoting a culture of Quality and to meet business, quality, and regulatory objectives.

Duties and Responsibilities:

• Build and manage a manufacturing engineering team for DSDP cells and combination products

• Act as primary technical and engineering manufacturing lead design reviews, documentation with focus on designing for manufacturability.

• Implement, propose and drive the implementation of Drug Product Device and manufacturing engineering controls by integrating Vertex QMS, production controls, risk assessments.

• Drive CMC Cell manufacturing project plans to support clinical development, submission, and approval of drug-device combination product to support the Type 1 Diabetes pipeline within internal manufacturing team.

• Serve as the main point of contact for cross-functional teams to ensure that all activities driving combination product manufacturing deliverables are aligned and on track. Serve as the MFG lead for tech transfer of new cell and combination DSDP processes and products.

• Develop, foster, and lead a team of highly driven subject matter experts and engineers to trouble shoot manufacturing issues.

• Support successful Clinical and commercial batch disposition across Vertex's internal and external manufacturing sites.

• Identify and communicate risks and assist with risk mitigation plans as necessary.

• Oversees MFG assessment, approval and implementation of investigations and change controls.

• Represent manufacturing group in combination device programs- participate in complex project involving medical device and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.

• Foster collaboration, problem solving, and solution-set thinking with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.

• Regularly interacts with functional areas beyond CMC, such as Regulatory, Quality, Supply Chain, Technical Operations and Clinical.

• Review and approve the critical process parameters for cell and combination products from manufacturing feasibility and operational efficiency standpoint.

• Strategically plan and set a vision to lay out upcoming new facility requirements for cell and combo products at manufacturing sites.

• Participate in Operational and Capital budgets.

• Develop and delivery on key performance indicators (KPIs) in collaboration with MFG leadership.

• Assign tasks to internal team members and working teams, within a defined governance model

• Collaborate with workstream leads to relay recommendations, decisions, actions, and other pertinent information related to the development and manufacturing of the cell and combination product.

• Create, revise, and review controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing.

• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.

Knowledge and Skills:

• Strong understanding of Manufacturing Engineering principles in GMP and relevant regulatory requirements for cell and combination products.

• Comprehensive knowledge of Design Controls per 21 CFR 820

• Strategic leader with excellent people management and staff development background.

• Highly driven and self-motivated with out of the box thinking mindset.

• Capable of delivering quality results within tight deadlines.

• Strong understanding of medical device related combination therapies.

• Strong verbal and written communication skills, with the ability to effectively communicate complex ideas and goals to various team members and stakeholders.

• Excellent communication and interpersonal skills, with the ability to lead and work effectively with cross-functional teams and external vendors.

• In-depth knowledge of the development process, including scale-up and manufacturing, for combination products.

Education and Experience:

• BS, Master's Degree or PhD in life science, Chemical/ Mechanical engineering or equivalent

• 5-8 plus years of biopharma manufacturing experience or the equivalent medical device combination product experience.

• Knowledge of GMP, FDA and EMA regulatory requirements applicable to Device and/or Combination products

• Broad medical device /combination device technical knowledge of current industry trends.

• Proven ability to develop strategies and lead improvement projects-Experience with Root Cause * Analysis, and other Operational Excellence experience.

• A minimum of 3 years people management experience.

• Strong Knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)

• Excellent communication skills and a track record working in a matrix environment; Influencing/building/promoting a culture of Quality.

• Leads with emotional intelligence and strives to be agile in complex and uncertain situations.

• Strong leadership through a partnership and engagement approach with manufacturing for advancing quality outcomes and operational excellence.

• Ability to apply risk management principles to decision making and operational priorities

• Strong experience in managing cross-functional teams involved in the development, scale-up, technology transfer and manufacturing of therapeutic combination products in a GMP environment.

• Expertise in cell processing and culture technologies for clinical materials production.

Environment:

• Works in a cleanroom and office setting

• Frequently move about inside the cleanroom to accomplish process tasks or oversee operations.

• Occasionally moves lab equipment and materials weighing up to 50 pounds.

• Compressed gasses and LN2 are used in this process.

Other Requirements

• In this On-Site designated role, you will work five days per week on-site in Boston, with ad hoc flexibility.

• Travel to domestic and international partner sites may be required (up to 20%)

#LI-Onsite

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