Sr Engineer I/II, Process Development

  • location: Norwood, MA
  • type: Permanent
  • salary: $110,000 - $130,000 per year
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job description

Sr Engineer I/II, Process Development

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

location: Norwood, Massachusetts
job type: Permanent
salary: $110,000 - 130,000 per year
work hours: 8 to 4
education: Bachelors
We are seeking a highly skilled and motivated process development Engineer within the Technical Development organization. This role will develop, scale-up, and transfer new and improved production processes for our first-in-class messenger RNA (mRNA) based medicines to enable our clinical supply and late stage development.

We are developing first-in-class mRNA-based vaccines and therapeutics. The mRNA is packaged into lipid nanoparticles for storage and delivery. The Process Development group is focused on unit operations that are standard across the industry such as normal and tangential flow filtration and chromatographic purification. We are also designing scalable operations specifically invented to form our lipid nanoparticles, to encapsulate the mRNA, and to physically stabilize the particles. The person in this role will have the opportunity to design, optimize, and transfer these unit operations for scale-up and late-stage clinical supply. In addition, the person in this role will be part of a late-stage development team focused on process robustness/characterization, understanding product quality, and refining the control strategy.

Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. Collaboration through cross-functional matrix teams and excellent communication skills are required. The candidate must have strong skills in designing and executing bioprocess experiments. Results will be presented to broader groups allowing exposure across the Technical Development organization.

We seek applicants that are proactive, enthusiastic, and show a passion for process development. Applicants should have exceptional time management and communications skills with a strong attention to detail. Previous experience with chromatography, nanoparticle formulations, filtration technologies, mixing technologies, tangential flow filtration, process robustness, process characterization, and design of experiments is preferred.

  • Design, execute, and analyze experiments for existing and novel process modes
  • 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, communicate findings internally and externally, and present in cross-functional meetings
  • Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups. Optimize current processes to ensure robust manufacturing of mRNA therapeutics
  • BS or MS in Bio/Chemical Engineering, Bio/Chemistry, or closely 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
  • Ability to thrive in a diverse and fast paced environment
  • Excellent written and verbal communication skills
  • Preferred: Experience with nanoparticle formulations
  • Preferred: Familiarity with nucleic acid, protein, and/or lipid chemistry, enzyme kinetics, and analytical characterization of biomolecules
  • Preferred: Hands-on experience with AKTA FPLC, Tangential flow filtration (TFF), and HPLC/UPLC instrumentation, JMP statistical software
skills: HPLC, Analytical Chemistry, Chemistry, 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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