Product Development Senior Scientist

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make: As a Senior Scientist in Product Development, you will be a scientific leader independently driving complex formulation and combination product development activities. You will support the design, development, and commercialization of drug-device combination products, significantly contributing to product strategy, regulatory submissions, and cross-functional collaboration. Your deep technical expertise and leadership will advance the lifecycle development of innovative combination products that improve patient outcomes globally.

Responsibilities:

• Serve as a technical lead in the design and development of complex pharmaceutical formulations and integrated delivery systems (e.g., nasal sprays).
• Drive formulation strategies from early-stage development through process scale-up, technology transfer, and commercialization.
• Lead the evaluation and selection of delivery devices, conduct risk assessments, device feasibility testing, and cross-functional alignment on target product profiles.
• Plan and execute studies for extractables/leachables (E&L), container closure integrity (CCI), device compatibility, device reliability, and functionality.
• Represent Product Development in cross-functional teams (e.g., CMC, Regulatory, QA, Engineering, Manufacturing) and provide strategic input to development timelines and regulatory strategies.
• Author and review regulatory documentation for combination products (e.g., IND, NDA, IMPD), including development reports, justification of specifications, and 21 CFR Part 4-compliant documentation.
• Support Design Control activities and participate in design verification, validation, and risk management (FMEA, ISO 14971) for combination products.
• Mentor and coach junior scientists and associates, fostering a collaborative, high-performance team environment.
• Contribute to the identification and implementation of innovative technologies and analytical tools within the product development function.
• Maintain compliance with all applicable regulations and internal procedures, including cGMP, ISO 13485, FDA/EMA guidelines.
• Design and execute projects related to continuous improvement initiatives and innovation within the product development function.
• Stay current with advancements in technologies, industry best practices, and regulatory expectations.
• Prioritize personal workload to ensure that key objectives are met on time and to budget.
• Implement new techniques and instrumentation to expand internal capabilities.
• Utilize creative thinking to generate solutions to complex technical problems.
• May be required to travel to attend/present at industry conferences and/or support execution of robustness studies.

Qualifications:

• Degree in scientific field: BS with 6+ years’ experience, MS with 3+ years’ experience, PhD with 0+ years’ experience
• Proven track record in drug product formulation and device development, particularly with combination products
• Strong working knowledge of regulatory expectations: FDA, EMA, cGMP, ISO 13485, and 21 CFR Part 4
• Experience contributing to or leading regulatory submissions for combination products
• Demonstrated leadership in cross-functional settings and ability to manage complex technical projects
• Excellent written and verbal communication skills, including authorship of technical reports and regulatory documentation
• Experience with nasal spray drug products and devices a plus
• Strong analytical and organizational skills
• Effective communicator with ability to collaborate across disciplines
• Curious and proactive learner, especially in multidisciplinary areas like drug-device integration

Physical Requirements:

• Employee is required to regularly use hands to handle materials and supplies.
• Employee is required to use computers for an extended period each day.
• Employee is required to effectively use communication by both telephone and electronic means.
• Employee is required to regularly stand and walk for extended periods.
• Employee must occasionally lift and/or move up to 25 pounds.
• Ability to use proper lifting techniques and be conscious of work area hazards.
• Employee is required to follow all site safety procedures.

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