Senior Scientist I, Analytical Chemistry

Kindeva Drug Delivery•Lexington, KY

2d•Onsite

About The Position

Join a growing pharmaceutical CDMO where your expertise will directly support the development of innovative drug products that improve patient health worldwide. As a Senior Scientist, Analytical Chemistry, you will serve as a technical leader within the R&D Analytical Chemistry group, leading analytical strategies that support pharmaceutical product development from early-stage development through commercialization. You will provide scientific leadership in method development, validation, verification, transfer, and troubleshooting activities while partnering with cross-functional teams to advance customer programs and internal development initiatives. This role is ideal for a scientist who thrives in a fast-paced development environment, enjoys solving complex technical challenges, and is passionate about mentoring others while advancing analytical capabilities within a growing organization. Our Lexington site continues to experience significant growth across development and manufacturing programs. This position offers the opportunity to lead complex analytical projects, support innovative drug development programs, influence technical strategy, mentor junior scientists, and expand Kindeva's analytical capabilities while working closely with customers and internal development teams.

Requirements

PhD in a scientific discipline with 1+ years of relevant experience; Master's degree with 3+ years of experience; Bachelor's degree with 6+ years of experience; or 9+ years of equivalent experience without a degree.
In-depth experience with analytical techniques including HPLC, UPLC, GC, UV, FTIR, spray testing, compendial methods, and related analytical technologies.
Demonstrated success in analytical method development, optimization, validation, and troubleshooting under GMP and ICH guidelines.
Strong understanding of regulatory requirements and CMC components of pharmaceutical drug development.
Experience with stability testing, impurity/degradant characterization, and forced degradation studies.
Proven ability to lead technical projects and work effectively within cross-functional teams.
Strong written and verbal communication skills, including experience authoring technical and regulatory documentation.
Demonstrated ability to mentor, influence, and develop junior scientists and technical staff.
Employee is required to regularly use hands in order to handle laboratory materials and supplies.
Employee is required to use computers for extended periods each day.
Employee is required to effectively communicate through both verbal and electronic means.
Employee is required to regularly stand and walk for extended periods of time.
Employee must occasionally lift and/or move up to 25 pounds.
Ability to use proper lifting techniques and remain aware of laboratory and workplace hazards.
Employee is required to follow all site safety procedures and wear appropriate PPE.

Nice To Haves

Experience with nasal spray drug products and device-related analytical testing is preferred.
Experience within pharmaceutical, biotechnology, contract development and manufacturing (CDMO), or regulated product development environments strongly preferred.

Responsibilities

Lead the development, optimization, and validation of robust analytical methods for drug substances and drug products in accordance with ICH, USP, and regulatory guidelines.
Design and execute complex analytical studies to support formulation development, process development, stability programs, and customer projects.
Lead or support technology transfer of analytical methods to internal and external QC laboratories and CMOs.
Support qualification of new analytical laboratory equipment.
Implement new analytical techniques and instrumentation to expand internal capabilities.
Act as a subject matter expert (SME) for analytical technologies, method troubleshooting, and regulatory inspections.
Provide leadership and execution of complex scientific experiments.
Utilize creative thinking to generate solutions to complex technical problems.
Prioritize personal workload to ensure key objectives are achieved on time and within project expectations.
Stay current with advancements in analytical technologies, industry best practices, and regulatory expectations.
Mentor and provide technical oversight to junior scientists and analysts, ensuring scientific rigor and compliance with quality standards.
Author and review technical documents, including method validation protocols and reports, specifications, analytical development reports, and regulatory submissions (IND, NDA, ANDA, BLA).
Prepare and maintain accurate and timely laboratory records in accordance with company policies and regulatory requirements.
Ensure compliance with GMP requirements, regulatory expectations, and internal quality systems.
Support regulatory inspections, customer audits, and compliance initiatives as required.
Collaborate cross-functionally with Formulation Development, Process Development, Quality Assurance, Regulatory Affairs, Manufacturing, and customer teams to ensure successful product development.
Represent Analytical Chemistry in project meetings and customer meetings with limited supervision.
Contribute to continuous improvement initiatives and innovation within the analytical development function.
Support Marketing and Business Development activities through technical presentations, posters, publications, blogs, white papers, and industry conferences.
Support cross-functional training and execution of activities within the R&D Product Development & Design Team as needed.