Position Overview:

Beam is looking for a highly motivated Engineer/Senior Engineer to join our growing Manufacturing Sciences & Technology (MS&T) team. The MS&T Engineer will be responsible for supporting process technology transfers and GMP manufacturing at the Beam Durham facility. Support includes technical support and subject matter expertise for bulk drug substance and bulk drug product GMP clinical, PPQ, and commercial manufacturing. This role supports the execution of the CMC program strategy through strong collaboration and partnership with cross-functional team members in Process Development (PD), Analytical Research and Development (ARD), Manufacturing, Supply Chain, Quality Control, and Quality Assurance.

Responsibilities:

• Supports MS&T activities related to mRNA and LNP programs

• Supports the technology transfer and implementation of mRNA and LNP GMP manufacturing processes, collaborates with sending and receiving site cross-functional team members

• Supports bulk drug substance and bulk drug product manufacturing across the full product lifecycle, including process design, process performance qualification (PPQ), commercial production, and continued process verification (CPV)

• Authors technical documentation, including technology transfer plans, facility fit and gap analysis reports, manufacturing study protocols and reports, and risk assessments

• Supports equipment design to meet process needs and compliance/regulatory expectations; supports Engineering and Validation departments with subsequent procurement, qualification, and GMP readiness

• Supports regulatory submissions, responses, on-site audits, and inspections

• Represents MS&T in cross-functional teams related to mRNA/LNP programs and manufacturing operations

• Provides person-in-plant (PIP) support in manufacturing at Beam Durham

• Supports MS&T lab and non-GMP analytical testing of in-process intermediates, as needed

• Establishes trusting and collaborative work relationships across and between Beam sites

• Accommodates a flexible schedule during GMP manufacturing, which may include PIP support for critical operations outside of normal business hours

Qualifications:

• Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or equivalent with minimum 6 years of relevant work experience, or a M.S. degree with a minimum of 8 years of relevant work experience, or a B.S. degree with a minimum 10 years of relevant work experience. Level will be commensurate with experience and academic background.

• Demonstrated experience in technology transfer, scale-up, and implementation of downstream unit operations, such as, tangential flow filtration, normal flow filtration, and chromatography; direct experience in downstream process development is preferred

• Experience in executing Process Validation lifecycle approach; i.e. process design, PPQ, and CPV

• Experience in leading cross-functional teams for non-conformance event investigations, Root Cause Analyses (RCAs), and CAPAs

• Experience with DLS, UV spectroscopy, and UPLC/HPLC analytical testing methods is a plus

• Outstanding written, verbal, and presentation skills; ability to communicate strategies, plans, and results to a diverse audience

• Ability to simultaneously manage multiple projects and priorities and adjust quickly to dynamic situations

• High degree of customer focus and collaboration in a team environment