Oral Formulation Development

Pinnacle Medicines, Inc.; Doylestown (Bucks County); On-site; USD 150,000 - 190,000; Full time

Job summary

Pinnacle Medicines, Inc. seeks a Principal Scientist for Oral Formulation Development at our Doylestown, PA site. You will lead clinical formulation development and provide technical guidance to CDMOs.

The ideal candidate has deep formulation science expertise, extensive oral drug product experience, and applies emerging technologies to advance programs. You will design studies, collaborate across functions, and contribute to regulatory submissions, publications, and IP initiatives while

Qualifications

• Ph.D., master’s degree, or equivalent in pharmaceutical sciences, engineering, or a related field with at least 3 years of industry experience.
• Extensive experience in oral formulation development with ability to work independently.
• Strong GMP understanding and analytical techniques.

Responsibilities

• Lead oral formulation development for clinical candidates to optimize bioavailability and PK.
• Provide technical direction and oversight to CDMOs for clinical drug products.
• Identify formulation, stability, and process risks and develop mitigation strategies.

Skills

Oral formulation development

CRO/CMO management

Team collaboration

Data analysis & visualization

Publications/patents

Regulatory submissions support

Education

Ph.D., master’s degree or equivalent

Job description

We are seeking a Principal Scientist, Oral Formulation Development at our Doylestown, PA site. This role will lead clinical formulation development and provide technical guidance and oversight to contract development and manufacturing organizations (CDMOs). The ideal candidate brings a deep understanding of formulation science, extensive experience in oral drug product development, and the ability to evaluate and apply emerging technologies.

Key Responsibilities

• Lead oral formulation development for 1–2 clinical candidates to achieve desired bioavailability and pharmacokinetic (PK) profiles.
• Provide technical direction and oversight to CDMOs developing clinical drug products. Proactively identify formulation, stability, and process risks and develop mitigation strategies. Troubleshoot technical issues promptly to maintain project timelines and ensure investigations are appropriately completed and closed.
• Stay current with pharmaceutical manufacturing science, scientific literature, and emerging technologies. Evaluate technologies, engineering capabilities, vendors, and collaborators to identify opportunities for innovation and improvement.
• Design and conduct studies efficiently, including hands-on laboratory work as needed.
• Collaborate with Process Chemistry/API, Drug Product Process Development, Analytical Development, Preformulation, Quality, Regulatory, and other functions to support project progression. Provide technical guidance on process development and manufacturing.
• Maintain detailed experimental records and contribute to regulatory submissions, scientific publications, and intellectual property initiatives supporting discovery, preclinical, and clinical development.

Qualifications

• Ph.D., master’s degree, or equivalent in pharmaceutical sciences, engineering, or a related field, with at least 3 years of relevant industry experience.
• Extensive experience in oral formulation development, with the ability to work independently under minimal supervision.
• Strong understanding of formulation science, pharmaceutical engineering principles, Good Manufacturing Practice (GMP), and analytical techniques.
• Demonstrated experience leading projects with contract research organizations (CROs) and contract manufacturing organizations (CMOs).
• Ability to collaborate effectively with global teams across time zones and communicate clearly and respectfully in a fast-paced environment.
• Proven track record of technical contributions to projects, including patent co-inventorship and/or co-authorship of scientific publications or presentations.
• Ability to travel up to 20% domestically and internationally.

Preferred Skills

• Proficiency in data analysis and visualization tools.
• Hands-on GMP manufacturing experience with tableting, encapsulation, coating, granulation, hot-melt extrusion, milling, and spray drying.
• Strong learning agility, self-motivation, and commitment to high-quality execution.