Position Overview:

Beam has expanded our geographical footprint to RTP, NC with the addition of a 100,000 square foot manufacturing facility in addition to our laboratory-based facilities located in Cambridge, MA.  Beam is seeking a highly energetic Engineer II / Senior Engineer in the Manufacturing Sciences & Technology (MS&T) team to support site start up, technology transfer and cGMP implementation of mRNA and lipid nanoparticle (LNP) based therapeutics at our new RTP site.  The successful candidate will be responsible for providing operational and technical support for mRNA and LNP processes within the site.

The MS&T Engineer will lead and/or support internal technology transfers, provide technical support and subject matter expertise for mRNA and LNP processes in support of cGMP clinical manufacturing. As a key early hire within the new RTP site, this role will play a key role supporting the development of technical and operational documents. As the site transitions to clinical and future commercial cGMP production of novel mRNA and LNP therapeutics, this role will provide technical support to manufacturing, contribute to the readiness for process validation, and provide process technical support. Additionally, this role may engage with cross-functional CMC team members to support and execute the CMC agenda, including IND or BLA authorship support, as appropriate.

Key Responsibilities:

• Leads or supports the technology transfer and implementation of mRNA/LNP programs, collaborates with sending and receiving site cross-functional team members. 
• Leads or contributes to the establishment of technical documentation including tech transfer plans, facility fit and gap analysis reports, manufacturing study protocols and reports, standard operating procedures, process validation master plans/protocols/report, risk assessments, etc.
• Supports facility and equipment design and qualification to meet process and regulatory expectations.
• Establishes technical documentation including tech transfer planes, investigations, manufacturing study protocols and data analysis to support deviations and change controls.
• Supports regulatory submissions and responses, audits and regulatory inspections, as required.
• Represents the MS&T team within cross functional project teams related to the mRNA/LNP programs.
• Leads and/or assists with manufacturing deviation investigations and change controls.
• Provides Person-In-Plant (PIP) support to manufacturing, as required.
• Establishes and maintains strong relationships at the site and cross-functionally.
• Travel is expected to be up to 10% of time for in-person interactions with cross-functional partners and trainings.
• Must be willing to have a flexible schedule during initial site start up, which may include supporting critical operations outside of normal work hours, as needed.
• Must be able to work onsite.

Required Experience & Qualifications:

• Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or equivalent with minimum 2-6 years of relevant work experience, or a M.S. degree with a minimum of 4-8 years of relevant work experience, or a B.S. degree with a minimum 6-10 years of relevant work experience.
• Level will be commensurate with experience and academic background.
• Demonstrated technical expertise within downstream processing for production of large molecule biologics, gene, mRNA and/or LNP therapeutics (experience in mRNA/LNP production is preferred).
• Demonstrated experience in technology transfer and implementation of complex biologics processes.
• Prior hands-on purification development experience preferred.
• Strong background in drug development and regulatory requirements, fluency in process validation lifecycle requirements.
• Experience successfully leading manufacturing event investigations, Root Cause Analysis (RCA), and 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.