AD, Drug Product Development

Posted 17 November 2022
Job type Permanent
Contact NameSam Heron

Job description

BioTalent is excited to partner with a venture-backed biotech focused on combating neurodegenerative diseases through the use of complex protein biologics. Their mission is to promote brain health and repair through genetic and biochemical insights.


You Will:

  • Support and lead elements of formulation, process optimization, and scale up of manufacturing processes to deliver GLP & GMP drug product
  • Manage and collaborate with CMOs to develop drug product processes and to deliver GLP & GMP drug product
  • Collaborate with clinical to understand dosing regimens and support the generation of a delivery strategy
  • Use knowledge of process development and experience with relevant equipment to resolve technical process and scale up issues that may arise at any CMO
  • Oversight of container closure selection for drug substance and drug product as well as supporting filter validation, container closure qualification and other activities required to support initial IND
  • Work with process development to establish and implement assays
  • Author technical development reports, tech transfer documents and drug product related sections of regulatory submissions such as briefing books, IND
  • Collaborate with the Protein Sciences team to enable seamless transition between drug substance and drug product


Experience & Qualifications:

  • PhD & 6+ years of biotech/pharma industry experience in Pharmaceutics, Bioengineering, Chemical Engineering, Biochemistry, or related field
  • Solid technical knowledge and hands-on experience in biologic product formulation development, biophysical characterization, process development, scale up and technology transfer
  • Experience with lipid-based drug products or other nanoparticles strongly preferred
  • Demonstrated understanding of GMP regulations and FDA/EMA guidance on manufacturing process for biologic products
  • Successful management in the past of working with CMOs
  • Strong communication skills are required
  • Desire to work in a collaborative environment
  • Passion for curing neurodegenerative diseases is a plus


For more information about this opportunity, please apply to the role directly or contact Sam Heron at:

P: 617 412 7236