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.

# LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying. 
 
 

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!