Position Overview

Beam is seeking a highly motivated Engineer II for the Manufacturing Sciences & Technology (MS&T) team to support the technology transfer and cGMP manufacture of cellular therapy products at the Beam site in Durham, NC.

The MS&T Engineer will support internal technology transfers and provide technical support and subject matter expertise for cellular therapeutic processes in support of cGMP clinical manufacturing. As the site transitions from clinical to future commercial cGMP production of novel cellular based therapeutics, this role will contribute to the readiness and execution of process performance qualification (PPQ) and provide process technical support throughout. To accomplish these goals, this role will engage with cross-functional CMC team members to support and execute the CMC agenda, including IND or BLA authorship support, as appropriate.

Key Responsibilities:

• Supports MS&T activities related to autologous and allogeneic cell therapy programs.
• Supports the technology transfer and implementation of cell therapy programs and process improvements, collaborates with sending and receiving site cross-functional team members.
• Supports facility and equipment design and qualification, as needed, to meet process and regulatory expectations.
• Contributes to the development of site control programs such as process monitoring plan, microbial control plan, aseptic process simulation, and sterility assurance programs.
• Leads or contributes to technical documentation including technology transfer plans, facility fit and gap analysis reports, manufacturing study protocols and reports, standard operating procedures, process validation master plans/protocols/report, and risk assessments.
• Represents the MS&T team within cross functional project teams related to the cellular therapeutic programs.
• Leads and/or assists with technical manufacturing deviation investigations and change controls.
• Establishes and maintains strong relationships at the site and cross-functionally.
• Travel for in-person interactions and project meetings with cross-functional partners to ensure collaboration and seamless information transfer (travel up to 10% of time).
• Must be willing to have a flexible schedule during process start up and support, which may include supporting critical operations outside of normal work hours, as needed.

Required Experience & Qualifications:

• Ph.D. in Chemical Engineering, Bioengineering, Molecular & Cellular Biology, or equivalent with minimum 6 years of relevant work experience, M.S. degree with a minimum of 8 years of relevant work experience, or B.S. degree with a minimum 10 years of relevant work experience. Level will be commensurate with experience and academic background.
• Prior experience within upstream processing for production of large molecule biologics, gene and/or cell therapies (experience in cell therapy strongly preferred).
• Experience in leading or supporting the scale-up, technology transfer, and cGMP manufacturing of complex biologics.
• Experience successfully leading manufacturing investigations, Root Cause Analysis (RCA), and CAPA.
• Prior experience supporting late-stage process development, process characterization, or process performance qualification (PPQ) for cell culture processes is preferred.
• Exposure to drug development and regulatory requirements, fluency in process validation lifecycle requirements is preferred.
• 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 manage multiple projects and priorities and adapt quickly to changing circumstances.
• High degree of customer focus and demonstrated collaboration in a team environment.
• Results oriented with the ability to demonstrate resiliency, ownership and drive.