Engineer​/Sr Engineer, Manufacturing Sciences & Technology; mRNA​/LNP

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.

Beam is looking for a highly motivated Engineer/Senior Engineer to join our growing

Manufacturing Sciences & Technology (MS&T) team.

TheMS&T Engineerwillbe responsible forsupportingprocesstechnology transfers and GMP manufacturing at the Beam Durham facility.

Support includes technical support and subject matterexpertiseforbulk drug substance and bulk drug product

GMPclinical,PPQ, and commercialmanufacturing.

This role supports the execution of the CMC program strategythrough strong collaboration and partnershipwithcross-functional team membersin

Process Development (PD), Analytical Research and Development (ARD), Manufacturing, Supply Chain, Quality Control, and Quality Assurance.

• Supports MS&T activities related to mRNA and LNP programs
• Supports the technology transfer andimplementationof mRNAandLNPGMPmanufacturing processes, collaborates with sending and receiving site cross-functional team members
• Supportsbulk drug substance and bulk drug product manufacturing across the full product lifecycle, includingprocess design,process performance qualification (PPQ), commercial production, and continued process verification (CPV)
• Authorstechnical documentation,including technology transfer plans, facility fit and gap analysis reports, manufacturing study protocols and reports,andrisk assessments
• Supports equipment designto meet processneedsandcompliance/regulatory expectations; supports
  
  Engineering and
  
  Validation departmentswithsubsequentprocurement,qualification, andGMPreadiness
• Supportsregulatorysubmissions,responses,on-siteaudits,and inspections
• Represents
  
  MS&Tincross-functional teams related tomRNA/LNP programsandmanufacturingoperations
• Providesperson-in-plant (PIP) supportinmanufacturingat
  
  Beam Durham
• Supports
  
  MS&T labandnon-GMP analyticaltestingofin-process intermediates, as needed
• Establishestrustingand collaborativeworkrelationshipsacrossand between Beamsites
• Accommodatesaflexible schedule during
  
  GMP manufacturing,whichmayinclude
  
  PIPsupportforcritical operations outside of normalbusinesshours

• Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or equivalent with minimum6years of relevant work experience, or a M.S. degree with a minimum of8years of relevant work experience, or a B.S. degree with a minimum
  10years of relevant work experience.
  
  Levelwill becommensuratewith experience and academic background.
• Demonstrated experience in technology transfer, scale-up,and implementation ofdownstream unit operations, such as, tangential flow filtration, normal flow filtration, and chromatography; direct experience in downstream process development is preferred
• Experience in executing
  
  Process Validationlifecycle approach;i.e.process design,PPQ, and CPV
• Experienceinleadingcross-functional teamsfornon-conformanceevent investigations, Root Cause Analyses (RCAs), and CAPAs
• Experience with
  
  DLS, UV spectroscopy, and UPLC/HPLCanalyticaltesting methodsis a plus
• Outstanding written,verbal, and presentation skills;ability tocommunicatestrategies, plans,and results to a diverse audience
• Ability tosimultaneouslymanagemultiple projects and priorities andadjustquicklytodynamic situations
• High degree of customer focus and collaboration in a team environment

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.