Principal Scientist - Formulation

Innoviva Specialty Therapeutics • Lexington, MA

3d

About The Position

Nortiva Bio, Inc., a subsidiary of Innoviva, Inc., is a clinical-stage biopharmaceutical company focused on pioneering long-acting oral therapies using its proprietary LYNX™ drug delivery platform. This platform enables the creation of medicines designed to last a week or longer in a single oral dose, with a near-term focus on therapeutic areas where such dosing would improve adherence and health outcomes. The Principal Scientist - Formulation will lead Nortiva’s Formulation Team, driving formulation strategy from early-stage feasibility through clinical manufacturing. This role involves designing, manufacturing, and assessing polymer-drug blends for long-acting delivery, utilizing processes like hot-melt-extrusion, coextrusion, injection molding, spray coating, and laser welding. The ideal candidate will have a strong foundation in physical chemistry/material science, be adept at connecting processes to product attributes, and possess both strategic leadership and hands-on experimental skills in a fast-paced biotech setting.

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
• 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.

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

What This Job Offers

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