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Process Engineering Senior Manager

Semma Therapeutics

Semma Therapeutics

Providence, RI, USA
Posted on Thursday, July 13, 2023

Job Description

General Summary:

Reporting to the Associate Director of Commercial Process Engineering, this individual will be responsible for developing and executing the Process Engineering strategy relating to the design and development of medical devices intended to encapsulate a novel cell therapy for the treatment of Type 1 Diabetes. In addition, he/she will provide leadership in overseeing process validation, technology transfer, and implementation of continuous improvement initiatives. It is also expected that the incumbent will provide Engineering support to other groups, including R&D and manufacturing, as required. The position is based out of Providence, R.I.

Key Duties and Responsibilities:

  • Work with external contract organizations (Tier II and Tier III suppliers) and guide process development and validation activities related to device manufacturing

  • Provide technical engineering oversight from development, to the transfer and implementation to an external CMO and routine operation of process equipment/systems.

  • Develop process optimization/scale-up strategy and drive engineering initiatives to meet department and organizational objectives as the company prepares to begin clinical development.

  • Lead a team of process engineers involved in the design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices.

  • Effectively communicate technical results via presentations and data driven reports

  • Provide technical engineering expertise within multiple areas of responsibility, including engineering, validation, packaging, sterilization, and equipment/system development.

  • Ensure the development of detailed project plans and timelines, including resource and equipment needs, budgets, outside contractors, purchased equipment, and materials. Present to Senior Management as required.

  • Manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies or strategies. This may include economic, quality, and productivity analysis.

  • Responsible for ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability.

  • Establishes operating equipment specifications, defines process windows, and improves manufacturing techniques/processes.

  • Statistically characterizes processes and implement controls to ensure repeatability and consistency.

  • Support deviation management, CAPA, and change control activities, as required. Serve as process S.M.E. to Quality, Supply Chain, Manufacturing, and other Functions. Support manufacturing investigations, including OOS’s., OOT’s., RCA’s., etc.

  • Authors protocols, pFMEA’s, equipment and process documentation, SOP’s, and work instructions in compliance with VCGT quality management systems and industry regulations.

  • Coordinates activities of the department and with other functional leaders.

  • Performs other duties as assigned.

Knowledge and Skills:

  • B.S or M.S or PhD in engineering or another relevant discipline.

  • Minimum of 5-8 years of experience working within a medical device environment, with a minimum of 3 years in a managerial capacity. Experience with device-biologic combination products is highly desirable.

  • Proven experience with Process Development, Process Optimization, Scale-up, and Technology Transfers.

  • Strong understanding of Packaging and Sterilization requirements

  • Comprehensive knowledge of Design Control and Risk Management, including experience using F.M.E.A. analyses, is strongly advantageous.

  • A thorough understanding of c.G.x.P principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.

  • A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.

  • Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.

  • Must demonstrate strong interpersonal, teamwork, and team management skills.

  • Ability to organize a team through organizational changes

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