Senior/Principal Scientist, Formulation Development

Treeline Biosciences • Watertown, MA

6h • $165,491 - $181,963

About The Position

The Senior/Principal Scientist, Formulation Development is responsible for supporting phase appropriate formulation development for preclinical and clinical use through external CDMO partners. This individual will work closely with CMC, quality, regulatory, and clinical supply through all phases of drug development.

Requirements

• Ph.D. in pharmaceutical sciences or related discipline and a minimum of 3-6+ years of relevant pharmaceutical experience in process chemistry; or M.S. in pharmaceutical sciences or related discipline and a minimum of 10-13+ years of relevant pharmaceutical experience
• Formulation development expertise across a broad range of dosage forms. Experience developing phase appropriate drug product development.
• Prior experience working in a virtual CMC development environment with external CDMO partners.
• Strong understanding of GMP requirements for drug product development
• Experience in the preparation and review of regulatory filings (including INDs, IMPDs, or other regulatory dossiers)
• Focused on collaboration. Building and maintaining good working relationships with internal and external stakeholders is essential. Strong communication skills, both written and oral.
• Ability to work in a fast-paced and dynamic corporate environment with changing priorities and meet time sensitive program deadlines.
• Willingness to travel to various meetings or client sites, domestically or internationally when necessary.

Responsibilities

• Provide technical oversight for formulation development and GMP manufacturing.
• Collaborate with CMC, Medicinal Chemistry, DMPK, Quality, Regulatory, and Clinical supply groups to advance preformulation and formulation plans.
• Proactively manage objectives, timelines, milestones, and budgets for formulation development and manufacturing activities
• Able to critically troubleshoot problems, determine underlying causes, and propose well thought out solutions within existing constraints.
• Develop strong, collaborative working relationships with external partners; critically assess progress and actively drive experimental workplans at external CDMOs.
• Maintain an understanding of current trends and emerging technologies in small molecule formulation development, including bioavailability enhancement.
• Effectively communicate project progress to internal management and external CDMO partners
• Authors technical summaries/reports and participates in the authorship and maintenance of CMC regulatory filings.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree