Our client, a global biopharmaceutical company that finds and delivers novel treatments for patients with a significant unmet need, has an immediate opening for a Senior Scientist.

Responsibilities:

• Serve as a formulation subject matter expert to cross-functional Technical Operations, CMC, and program teams
• Design and carry out formulation development and drug product development studies
• Analyze, trend, and interpret formulation development, stability, and production data
• Support technical oversight of drug product CDMOs and GMP manufacturing operations
• Review and approve GMP manufacturing and quality documents as a technical expert such as batch records and production data
• Develop, author, review, and approve protocols, reports, and process descriptions
• Contribute to regulatory filing submissions (such as IND, BLA, MAA)
• Stay current with the regulatory requirements, industry trends, and new emerging technologies as it relates to formulation development and drug product development
• Other duties as required

Requirements:

• BS/MS/Ph.D. in chemistry, biochemistry, (bio)chemical engineering pharmaceutical sciences (or other relevant physical or life sciences discipline). Graduate degree preferred
• 3-5+ years of biologics formulation development experience in pharma/biotech
• Experience with drug product development and in-use studies a plus
• Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to pre-formulation and formulation development, using a rational, scientific approach
• Hands on knowledge of common protein analytical techniques such as HPLC, DSC, iCIEF, CE-SDS, subvisible particle characterization, and biophysical methods
• Maintain a high level of productivity in the lab requiring only minimal direction
• Effectively and concisely communicate scientific rationale and data to project teams
• Strong technical writing and data analysis skills
• Experience in collaborating with external labs and CDMOs a plus