Senior Process Engineer I Job at Beam Therapeutics (Durham)

Job Description

As a key hire at the Beam North Carolina site (‘Beam NC’), the Senior Process Engineer will provide technical support to manufacturing operations at Beam. With autologous cell therapy, mRNA, and LNP manufacturing operations all occurring at the site, the Senior Process Engineer must be capable of developing subject matter expertise across a wide range of equipment and unit operations. Furthermore, as Beam expands its pipeline and the site advances towards commercial cGMP manufacturing, this role will play an essential role in technology transfer, process validation, and scale-up / scale-out initiatives. In addition to manufacturing support responsibilities, the Senior Process Engineer will be responsible for developing and administering the CapEx process at Beam NC. Success in this role will require the ability to work collaboratively with a variety of stakeholders and balance competing priorities.

Job Responsibility

Act as subject matter expert for CGT equipment and processes in support of cGMP clinical and commercial manufacturing, with focus on the commercialization of Beam’s autologous cell therapy program
Provide Person-In-Plant (PIP) support to manufacturing, as required
Support facility and equipment design and qualification to meet process and regulatory expectations
Lead or contribute to the creation of technical documentation including project documents, equipment preventive maintenance and calibration procedures, process validation plans/protocols/reports, risk assessments, etc
Support deviation and change control generation, review, and execution
Own and manage small CapEx and process improvement projects for the Beam Engineering and Facilities team, and support larger CapEx projects as the process engineering lead
Supports regulatory reviews and responses, audits and regulatory inspections, as required
Represent the Beam NC Engineering & Facilities team within cross functional project teams as required
Establish and maintain strong relationships cross-functionally within the broader Beam Team
Ensure safety, compliance and sustainability throughout the engineering functions

Requirements

BS in Chemical Engineering, Bioengineering, Biochemistry, or similar with minimum 5 years of relevant work experience, or a M.S. degree with a minimum of 3 years of relevant work experience
Demonstrated technical expertise within autologous cell therapy, mRNA, and/or LNP therapeutics (experience in CGT manufacturing is preferred), downstream processing for production of large molecule biologics, gene therapy
Experience in single-use systems, closed processing, and aseptic manufacturing techniques
Experience successfully leading manufacturing event investigations, Root Cause Analysis (RCA), and Corrective and Preventative Action (CAPA)
Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience
Dynamic interpersonal skills and the ability to manage through influence
Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances
High degree of customer focus (internal/external) and demonstrated collaboration in a team environment
Results oriented with the ability to demonstrate resiliency, ownership, and drive
Must be able to work onsite at our Durham, NC facility

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