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

E: sam.heron@biotalent.com