Relate Search has partnered with a leading organization in the development and commercialization of dietary supplement, OTC, and pharmaceutical products to identify a Senior Principal Product Development Engineer who will serve as a senior individual-contributor technical expert in oral dosage form product development.

This highly technical role will provide scientific and technical direction across formulation, process development, scale-up, commercialization, CMC readiness, and regulatory filing support. The ideal candidate brings deep experience with pharmaceutical and/or OTC product development, particularly oral dosage forms, along with demonstrated expertise supporting NDA, ANDA, and 505(b)(2) regulatory strategies.

As a recognized subject matter expert, this individual will apply advanced formulation, processing, engineering, and Quality by Design principles to solve complex development challenges, establish technical strategy, and influence cross-functional decisions through experimentation, data, risk assessment, and sound technical rationale. The role will also help strengthen organizational Quality by Design practices through technical standards, coaching, training, and cross-functional collaboration. Relocation is offered to non-local candidates.

Responsibilities

• Lead research and development initiatives supporting strategic product platforms across dietary supplements, OTC products, and pharmaceutical products, including products developed under NDA, ANDA, and 505(b)(2) pathways.
• Provide senior technical leadership across formulation, process development, experimental design, scale-up, validation support, technical transfer, commercialization, and CMC documentation for regulated oral dosage forms.
• Apply and deploy Quality by Design principles, including critical quality attributes, critical process parameters, design space, risk assessments, design of experiments, control strategies, and lifecycle development approaches.
• Evaluate complex scientific, technical, and regulatory data and translate findings into clear technical recommendations that support product development, regulatory, manufacturing, and filing decisions.
• Serve as a recognized technical subject matter expert, providing technical guidance and coaching to scientists and technicians while partnering cross-functionally with R&D, Quality, Regulatory Affairs, Manufacturing, Validation, Operations, Purchasing, and other stakeholders.

Qualifications

• Must have pharmaceutical and/or OTC product development experience, with a strong track record developing and commercializing regulated oral dosage forms in a cGMP environment.
• Bachelor’s degree in Pharmaceutical Science, Chemical Engineering, Food Science, Chemistry, or a related scientific discipline with 12+ years of relevant product development experience, or a Master’s/PhD with 10+ years of relevant experience in OTC, pharmaceutical, and/or dietary supplement product development.
• Demonstrated experience supporting U.S. regulatory pathways including NDA, ANDA, 505(b)(2), and/or OTC monograph products, including CMC strategy and technical submission content.
• Expert-level knowledge and practical application of Quality by Design, including risk assessment, design of experiments, critical quality attributes, critical process parameters, control strategy, process capability, and formulation/process design space.
• Proven ability to communicate complex scientific and technical concepts effectively, troubleshoot development challenges, influence cross-functional decisions, and provide clear, data-driven recommendations without direct people-management responsibility.

About Relate Search

Relate Search is a Woman, Minority, and LGBTQIA+ owned executive and professional search firm dedicated to connecting top talent with meaningful opportunity. With deep expertise across Supply Chain & Operations, Technology, Sales & Marketing, Human Resources, and Accounting & Finance, we deliver customized, people-first recruiting solutions that drive lasting impact.



Equal Opportunity & Diversity Statement

Relate Search is proud to be an Equal Opportunity Employer. We value diversity and are committed to building inclusive teams where everyone belongs. All qualified applicants are encouraged to apply.