Associate Director Process Engineering
Company: Vertex Pharmaceuticals Inc (US)
Posted on: January 12, 2021
In June 2019, Vertex announced the establishment of new research
sites in Boston and Providence 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 treat-and
even cure-several 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 Vertex's
continued and sustained leadership in these exciting approaches. At
Vertex Cell and Genetic Therapies (V.C.G.T.), 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.Reporting to the Director of Process Engineering, this
individual will be responsible for the implementation of 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,
automation, 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 Responsibilities:
- Lead Process Engineering initiatives, contribute to Process
Development strategy and manage Engineering Resources to achieve
Technical Operations Objectives. Will have responsibility for
hands-on development of processes relating to polymer synthesis,
molding, assembly, packaging, and sterilization of medical
- Lead a team of process engineers involved in the design and
development of equipment, processes, and control systems, used for
the production and assembly of cell encapsulation devices.
- 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, automation initiatives, and modifications
to existing systems to consider new processing technologies or
strategies. This may include economic, quality, and productivity
- Manage all aspects of Product Transfer, from the process
establishment stage for early-stage clinical manufacturing through
commercial c.G.M.P. production, ensuring that project objectives
and timelines are achieved, and work is thorough and
- Establish robust process performance across all clinical and
commercial manufacturing lines, including process development,
process improvement, and maintenance of process excellence. Lead
process monitoring, continuous improvement, and lifecycle
management initiatives. Establish K.P.Is. and manage performance
- Collaborate with Research and Development, Manufacturing,
Quality, Analytical Development, and Supply Chain to support a
phase-specific "design for manufacturability" mentality and
manufacturing performance. Lead process optimization
- Review and/or draft internal Batch Records, Engineering
Protocols and Reports, and other Quality System Documentation.
- Support Deviation Management, C.A.P.A., and Change Control
activities, as required. Serve as process S.M.E. to Quality, Supply
Chain, Manufacturing, and other Functions. Support manufacturing
investigations, including O.O.Ss., O.O.Ts., R.C.As., etc..
- Represent the department on cross-functional teams, establish
priorities, and provide updates to Senior Management on all
Technology Transfer and Technical Operational activities.
- Execute assigned duties on time and within budget; pro-actively
telegraph delays and other issues to relevant stakeholders.
- Comply with all regulatory, corporate, and Quality System
policies and complete other projects and/or assignments as
- B.S. or M.S. in engineering or another relevant
- Minimum of 8 years of experience working within a medical
device process development environment, with a minimum of 3 years
in a managerial capacity. Experience with device-biologic
combination products is highly desirable.
- Ability to organize a team through organizational changes.
- Proven experience with Process Development, Process Technology
Transfer, Technical Operations, and Lifecycle Management.
- Experience validating manufacturing processes is required.
Knowledge and experience in utilizing risk-based approaches to
validation process development and validation are highly
- Comprehensive knowledge of Design Control and Risk Management,
including experience using F.M.E.A. analyses, is strongly
- Familiarization with ISO 13485, ISO 14971, and 21C.F.R.820.
Knowledge of global GMP requirements governing device or
- A strong understanding of statistical analyses is required, as
are strong technical writing and presentation skills.
- Sense of urgency, ability to act/escalate promptly, and
transparently communicate issues to involved stakeholders and
- Must be able to work independently with adequate supervision,
multi-task, and support several projects simultaneously.
- Knowledge of business applications such as OPM (Oracle),
QDocCS, Trackwise/Veeva, MS Office.
- Must demonstrate strong interpersonal, presentation, and
Keywords: Vertex Pharmaceuticals Inc (US), Providence , Associate Director Process Engineering, Engineering , Providence, Rhode Island
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