Principal Scientist - Formulation

Responsibilities

• Serve as the technical lead for formulation development of long-acting oral drug products
• Develop formulation strategies and work plans based on API properties, pharmacokinetic targets, and historical data
• Guide budgeting and resourcing for formulation efforts, ensuring progress against formulation milestones and company timelines
• Establish, oversee, and contribute to the execution of experimental plans to optimize formulation composition, performance, and manufacturability
• Lead scientific problem solving related to formulation performance, scale-up, stability, and manufacturability
• Partner closely with Analytical and Engineering teams to establish appropriate test methods, assess product quality, and scale up manufacturing operations
• Communicate results and progress to external partners
• Oversee the maintenance of laboratory equipment and establish laboratory protocols
• Provide technical mentorship to scientists and research associates within Pharmaceutical Sciences
• Author regulatory documents, formulation development reports, technical summaries, and SOPs

Requirements

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Materials Science, Chemistry, or a related discipline
• 10+ years of industry experience in pharmaceutical formulation and drug product development, including significant experience with oral solid dosage forms
• Experience authoring regulatory submission documents and working in a GMP environment
• Demonstrated contributions to patents or proprietary drug delivery technologies
• Demonstrated experience leading, mentoring, and developing high-performing scientific teams, with a proven ability to coach and motivate scientists in a collaborative environment
• Experience working in small biotech or other highly collaborative, fast-paced environments

Skills and Abilities

• Demonstrated expertise in controlled-release formulation technologies and drug release mechanisms
• Strong understanding of formulation-process-performance relationships and pharmaceutical material properties
• Proven scientific leadership with the ability to independently solve complex technical challenges
• Excellent scientific communication and technical writing skills
• Ability to lead cross-functional teams and effectively manage external CRO/CDMO partnerships
• Strategic thinker with the ability to balance scientific rigor, innovation, and execution in a fast-paced environment