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Senior Associate Engineer/Engineer I
Manufacturing Sciences & Technology
Confirmed live in the last 24 hours
Locations
Research Triangle, Durham, NC, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Requirements
  • Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or equivalent with minimum 0-2 years of relevant work experience, or a M.S. degree with a minimum of 0-4 years of relevant work experience, or a B.S. degree with a minimum 2-6 years of relevant work experience
  • Level will be commensurate with experience and academic background
  • Prior experience within downstream processing for production of large molecule biologics, gene, mRNA and/or LNP therapeutics (experience in mRNA/LNP production is preferred)
  • Experience in supporting the scale-up, technology transfer and implementation of complex biologics processes
  • Prior experience supporting late-stage development, process characterization and/or process validation for biologics processes is preferred
  • Exposure to drug development and regulatory requirements, fluency in process validation lifecycle requirements is preferred
  • 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
Responsibilities
  • Supports MS&T activities related to mRNA and LNP therapeutics
  • 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
  • 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
Beam Therapeutics

501-1,000 employees