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 I 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 the 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 is a plus
• Strong analytical and organizational skills
• Effective communicator with the 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.