PD (Ops) Senior Scientist – Drug Substance

Senior Scientist – Drug Substance
 

Our client is a fast-paced innovative company that has recently brought on-line a brand-new production facility purposefully designed to manufacture our Oncolytic Immunotherapies.  This multi-product facility in Framingham contains cGMP manufacturing for both drug substance and drug product, as well as process development laboratory space.  The Senior Process Development Scientist – Drug Substance will lead and supervise drug substance process development lab-based process characterization and optimization activities and personnel in support of commercialization.  In addition, the Senior Process Development Scientist – Drug Substance will co-manage the development laboratories with the site Analytical Development lead.  The ideal candidate will have sufficient experience in both upstream unit operations (e.g. single use bioreactors) and downstream unit operations (e.g. TFF and chromatography).

Key responsibilities:

  • Drug substance technical lead within the Process Development teams (UK and US based) that ensures appropriate process development characterization / optimization experiments are being successfully executed to plan (upstream and downstream).
  • Design process development lab-based experiments to support process characterization / optimization.
  • Author / review protocols, reports, risk assessments, SOPs, and batch records
  • Author / review sections of applicable regulatory filings (e.g. process characterization, process control strategy, etc.)
  • Optimize and execute robust bench and pilot scale process steps including cell build, production bioreactor, and purification techniques such as filtration and chromatography.
  • Collaborate with manufacturing, QA, F&E, and other process development personnel to support and improve process steps within the production process.
  • Ensure effective, high-quality, timely, and appropriate documentation in laboratory notebooks.
  • Manage more junior lab-based staff.

 

Other responsibilities

  • Practices and promotes safe work habits and adheres to safety procedures and guidelines.
  • Provide technical representation during internal and external audits representing the process development lab function (lab activity quality compliance, process characterization experimentation, etc.)
  • Keeps up to date with current technologies and trends in biologics manufacturing operations and process development characterization.

 

Educational requirements:

  • Master’s degree in applicable field (chemical engineering, biology, etc.) and 4 to 6 years of related work experience

OR

  • Bachelor’s degree in applicable field (chemical engineering, biology, etc.) and 6 to 8 years of related work experience

 

 

 

Experience and skill requirement:

  • Hands-on experience in a biologics process development laboratory setting.
  • Prior experience as a people manager.
  • Demonstrated ability to work in cross-functional teams across the business.
  • Strong organizational skills and attention to detail.
  • Excellent written and oral communication skills and strong team player