Engineer III, Process Development

  • location: Norwood, MA
  • type: Permanent
  • salary: $130,000 - $180,000 per year
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job description

Engineer III, Process Development

job summary:
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location: Norwood, Massachusetts
job type: Permanent
salary: $130,000 - 180,000 per year
work hours: 9 to 5
education: Bachelors
The company is seeking an Engineer III to join the Process Development team to support development, scale up, transfer and commercialization of drug substances based on mRNA and lipid nanoparticle delivery technologies.

The company is developing first-in-class mRNA-based vaccines and therapeutics. The mRNA is packaged into lipid nanoparticles for storage and delivery. The candidate will be focused on unit operations that are standard across the industry such as normal and tangential flow filtration and chromatographic purification. The candidate will support commercial manufacturing processes and execute experiments to support deviation investigations and definition of appropriate process controls to increase process robustness. We are also designing scalable operations specifically invented to form our lipid nanoparticles, to encapsulate the mRNA, and to physically stabilize the particles.

Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. The successful candidate will possess strong skills in designing and executing high quality bioprocess experiments using quality by design (QbD) and Design of Experiment (DoE) methods, and will collaborate through cross-functional matrix teams. The person in this role will have the opportunity to develop on-line analytics, process modelling and process investigation support. Results will be presented to broader groups allowing great exposure to CMC Strategy, Regulatory, MS&T, and Quality. Prior experience of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.

In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support process investigations, support technology transfer and provide Person-in-Plant (PiP) support for commercial batches.

  • Design, execute, and analyze experiments for existing and novel process modes using DoE and statistical modeling
  • Define the process, the critical parameters, and the design space
  • Create high throughput and automated experimental setups
  • Lead experiments to confirm robust process performance across the control space
  • Characterize nanoparticle properties through collaboration with the analytical team
  • Prepare process descriptions, technical reports, and communicate findings internally and externally as appropriate
  • Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups.
  • BS/MS degree in Bio/Chemical Engineering, Bio/Chemistry, Pharmaceutical Science, or related field
  • BS with 5-8 years, or MS with 2-5 years of relevant industry experience in bioprocess development
  • Hands on experience with chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operations
  • Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data
  • Experience with analytics and biophysical characterization of nanoparticles is a plus
  • Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercialization
  • Demonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changes is a plus
  • Knowledge of nucleic acid chemistry, lipid chemistry, and biology is a plus
  • Ability to thrive in a diverse and fast paced environment
  • Excellent written and verbal communication skills

  • On-site subsidized cafeteria or catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter
  • Adoption assistance and discounts to local childcare centers, as well as access to
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
skills: Chromatography, ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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