What are the responsibilities and job description for the Engineer / Senior Engineer, LNP Manufacturing Sciences & Technology position at Beam Therapeutics Inc.?
Company Overview :
Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building 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 potential 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 seeking a highly capable Engineer / Senior Engineer in the Manufacturing Sciences & Technology (MS&T) team to support technology transfer and cGMP implementation of mRNA and lipid nanoparticle (LNP) based therapeutics 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 mRNA and LNP processes in cGMP manufacturing of early and late phase clinical material. As the site and programs transition to future commercial cGMP manufacturing, this role will partner with Manufacturing, Process Development, Quality Assurance, and Regulatory to ensure process control strategies are phase-appropriate and satisfy compliance and regulatory expectations. Additionally, this role will engage with cross-functional CMC team members to support and execute the CMC agenda, including support of regulatory filings, as appropriate.
Key Responsibilities :
- Leads and supports MS&T activities related to mRNA and LNP programs, such as facility fit, Technology Transfer, and cGMP manufacturing of early and late phase material for clinical studies.
- Collaborates with sending and receiving site cross-functional team members to implement safe, compliant, and robust process control strategies
- Authors and supports technical documentation, including Technology Transfer plans, facility fit and gap analysis reports, manufacturing study protocols and reports, standard operating procedures (SOPs), and risk assessments.
- Supports equipment selection, design, and CQV to meet manufacturing process requirements, compliance standards, and regulatory expectations.
- Provides Person-In-Plant (PIP) and frontline technical support during cGMP manufacturing runs.
- Supports Quality investigations by authoring technical impact assessments, designing and executing investigational study protocols and summary reports, and implementing robust corrective actions, as needed.
- Authors and supports technical Quality change controls by authoring, reviewing, and approving change plans, change actions, and associated deliverables.
- Supports regulatory submissions and responses, audits and regulatory inspections, as required.
- Represents the MS&T team within cross-functional project teams for the mRNA and LNP programs and other site initiatives.
- Establishes and maintains collaborative and trusting relationships with colleagues across departments and locations.
- Travel may be up to 10% of time to interact in-person with cross-functional partners, observe and participate in process development studies, and formal and informal training.
- Must be willing to have a flexible schedule during process start up and manufacturing runs, which may include supporting critical operations outside of normal work hours, as needed.
Required Experience & Qualifications :
