Manufacturing Process Engineering Manager - Drug Product, CMC Manufacturing

Job Description

At Vertex Biopharmaceutical Sciences and Manufacturing Operations (BSMO) organization our dynamic teams bring together the best biology, technologies, and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative cell and gene therapies (CGT) to patients as quickly as possible. At the newly designed Leiden Centre 1 site in Boston Seaport and other greater Boston locations, Vertex envisions growth of CGT pipelines research, development, and clinical manufacturing for emerging therapeutic modalities with the potential to treat-and even cure Type I Diabetes.

General Summary:

The Manufacturing Process Engineering Manager will be responsible for manufacturability, tech transfer, automation troubleshooting and manufacturing equipment of cell therapy and combination products, from clinical to early commercial manufacturing for our growing Type 1 Diabetes (T1D) program. In this role, you will be a part of newly formed manufacturing engineering team addressing issues on the floor for continuous seamless manufacturing of Drug Product. This position will partner with cross-functional stakeholders to lead technical transfer activities within Vertex's internal Process Development, Quality, Validation, Supply Chain, and Manufacturing teams and/or to external contract manufacturing organizations in support of developing operationally fit manufacture of drug products. The role will be responsible for inspiring, building and promoting a culture of quality and for meeting business, quality, and regulatory objectives.

Key Duties and Responsibilities:

• Improve Manufacturing process capability for Drug Substance (DS) and Drug Product (DP) of cell therapy and cell/device combination products

• Support ongoing cGMP manufacturing operations, new equipment and process technology transfers within the DP organization.

• Responsible for identifying equipment, automation, isolator systems and process issues for successful manufacturability on floor. Directly work with operations team on floor to address issues including automation recipe and system designs.

• Responsible for technical transfers and implementation of new equipment, process and technology including engineering designs, review of drawings and technicalities of implantable medical devices.

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

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

• Support Engineering design verification, IQ, OQ protocols, implementation of KanBan systems and LEAN models on operational floor.

• Improve Engineering procedures for new equipment's, automation checks, Engineering Lifecycle Documents, Process Flow Diagram development and Value stream mapping. Supporting automation and validation activities for all process equipment.

• Review Engineering and Systems process FMEAs, Design controls to ensure robust process was implemented within manufacturing.

• 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. Support Risk assessment, Impact Assessment, Deviations and investigations related to equipment controls.

• Participate as manufacturing SME for approval and implementation of investigations and change controls. Collaborate with internal engineering sites for improving manufacturing capabilities.

• 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.

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

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

• 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

• On-site position based in Boston, MA.

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

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.