Senior Process Engineer I

Position Overview:

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.

Responsibilities:

• 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.

Qualifications:

• 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.
• Level will be commensurate with experience and academic background.
• 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.