Summary of Position:

The Principal Scientist - Formulation is an experienced scientific leader who will lead Nortiva's Formulation Team. Nortiva's novel ultra-long-acting oral drug delivery platform uniquely combines elements of controlled drug delivery, traditional and non-traditional formulation components and processes, and dynamic structural features required for gastric residence.

The Principal Scientist - Formulation will be responsible for driving formulation strategy across multiple programs from early-stage feasibility through clinical manufacturing. This role will oversee and directly contribute to the design, manufacture, and assessment of polymer-drug blends for long-acting delivery. Nortiva's drug delivery platform combines traditional and non-traditional formulation processes such as hot-melt-extrusion, coextrusion, injection molding, spray coating, and laser welding. As such, the individual in this role must be well grounded in the fundamentals of physical chemistry/material science and capable of connecting processes to product attributes.

This position is ideal for a scientifically rigorous and entrepreneurial leader who enjoys both strategic leadership and hands-on experimental work in a fast-paced biotech environment.

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
• Manage external CROs/CDMOs to execute development activities
• 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

Experience & Education:

• 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.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.