Biologics Drug Substance Lead

Highly Competitive Salary
  1. Permanent
  2. Biological Sciences
  3. United States
Boston, Massachusetts
Posting date: 07 Feb 2019

At ProClinical, we are seeking an individual to fill the role of Drug Substance Lead, based in Boston, MA. The successful candidate will be responsible for technical oversight of Biologics Drug Substance development and manufacturing for the upstream and downstream process subject matter expert for outsourced drug substance development, manufacturing, technology transfer and regulatory submissions.


  • Establish/lead technical oversight at Drug Substance Contract Manufacturing Organizations.
  • Drive technical deviation investigations, change implementations and continuous improvement activities in alignment with Technical Team and Technical Operations Product Team goals.
  • Establish/Maintain Drug Substance Upstream and Downstream process monitoring for commercial products as part of robust Continuous Process Verification.
  • Lead scale-up, process validation activities.
  • Author CMC related sections for regulatory filings such as IND, IMPD, BLA etc.
  • Evaluate cell culture and scale-up technologies to reduce Cost of Goods.
  • Identify and help establish contracts and relationships with CDMOs developing stable cell line and upstream and downstream development of drug substance, and effectively manage the drug substance development activities in alignment with project team goals.
  • Maintain project specific budget and provides input to department budgets.

Skills And Education

  • BS in a related field and 8-10+ years' experience, OR MS/PhD in related field with 3-5+ years' experience in an up/downstream development/manufacturing environment.
  • Hands-on experience of biologic drug substance development and/or manufacturing, with thorough knowledge on upstream and downstream purification and strong understanding of analytics.
  • Experience working with single use technology
  • Experience and/or knowledge in stem cell and/or viral vector manufacturing is a plus.
  • Experience in managing Contract Development/Manufacturing Organizations.
  • Strong knowledge of relevant GxPs as well as applicable multinational regulatory guidelines.
  • Excellent written, verbal, and interpersonal communication skills.
  • Domestic and international travel up to 20%.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Hunter Tonn at (+1) 646-851-0086 or upload your resume on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.