LNP)

Beam Therapeutics•Cambridge, MA

3h•$100,000 - $135,000

About The Position

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. 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.

Requirements

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
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

Nice To Haves

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

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