Process Development Engineer

  • location: Norwood, MA
  • type: Permanent
  • salary: $95,000 - $110,000 per year
easy apply

job description

Process Development Engineer

job summary:
Great client is looking for a process engineer. 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.

 
location: Norwood, Massachusetts
job type: Permanent
salary: $95,000 - 110,000 per year
work hours: 9am to 6pm
education: Bachelors
 
responsibilities:
  • 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.
 
qualifications:
  • 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
 
skills: BioProcess Engineer, FDA, CAPA,

Benefits:

  • 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 care.com
  • 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)

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.

easy apply

get jobs in your inbox.

sign up
{{returnMsg}}

related jobs