Scientist II, Analytical Chemistry

Kindeva Drug Delivery•Lexington, KY

1d•Onsite

About The Position

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. We partner with leading pharmaceutical companies to develop and manufacture life-changing therapies that improve the lives of patients around the world. Joining Kindeva means becoming part of a collaborative team where your work directly supports the successful delivery of therapies from development through commercialization. You'll work alongside experienced scientists and cross-functional teams in a fast-paced, highly regulated environment where scientific excellence, innovation, and collaboration make a meaningful impact every day. Advance Science. Deliver Quality. Improve Lives. Reporting to the Manager, Analytical Chemistry, the Analytical Chemistry Scientist II supports the development, validation, and transfer of analytical methods for components, excipients, drug substances, and drug products across multiple stages of pharmaceutical development. In this role, you'll apply your analytical expertise to generate high-quality scientific data that supports formulation development, regulatory submissions, technology transfers, and commercialization activities. You'll collaborate with scientists, formulation development teams, quality, manufacturing, and external partners to develop robust analytical methods, troubleshoot technical challenges, and ensure laboratory activities are performed in compliance with cGMP, GLP, and regulatory requirements. Your scientific contributions will help ensure the safety, quality, and successful delivery of innovative therapies to patients around the world.

Requirements

PhD or MS with 0+ years of experience; or BS with 3+ years of experience; or 7+ years of experience without a Bachelor's degree.
Strong attention to detail and scientific rigor.
Ability to work both independently and collaboratively in a fast-paced environment.
Proficiency in analytical instrumentation and techniques including HPLC, GC, UV-Vis, FTIR, Karl Fischer, spray testing, and related analytical techniques.
Familiarity with cGMP, ICH, and FDA guidelines.
Competency in analytical data interpretation, documentation, and scientific reasoning.
Strong organizational, written, and verbal communication skills.
Ability to work independently and manage time efficiently.

Nice To Haves

Experience in an FDA-regulated environment.
Experience with nasal spray drug products and devices.

Responsibilities

Develop, optimize, validate, and transfer analytical methods supporting pharmaceutical development and commercialization.
Generate, interpret, and communicate analytical data to support formulation development, regulatory submissions, and technical decision-making.
Collaborate with cross-functional teams to solve complex analytical challenges and support technology transfer activities.
Maintain compliance with cGMP, GLP, and company quality standards while producing accurate scientific documentation.
Drive continuous improvement initiatives that enhance laboratory efficiency, analytical capabilities, and overall project success.
Perform routine and non-routine testing of raw materials, in-process samples, drug substances, and finished drug products to support formulation and process development.
Develop, optimize, and validate analytical test methods for components, drug substances, excipients, and drug products.
Interpret and report analytical data with a high degree of accuracy and scientific integrity.
Troubleshoot analytical methods and instrumentation, proposing and implementing effective solutions.
Support qualification of new analytical laboratory equipment.
Prepare technical documents including analytical method protocols, validation reports, technical reports, and SOPs.
Prepare and maintain accurate and timely laboratory records in accordance with company policies and regulatory requirements.
Ensure all laboratory work complies with cGMP, GLP, and company quality standards.
Participate in cross-functional project teams and contribute to CMC documentation for regulatory submissions (IND, NDA, ANDA).
Support method transfer and qualification activities to internal and external laboratories (e.g., CROs, CDMOs).
Prioritize personal workload to ensure that key objectives are met on time and to budget.
Implement continuous improvement projects that improve laboratory effectiveness and organization.
Support qualification of new analytical laboratory equipment.
Utilize creative thinking to generate solutions to complex technical problems.
Cross-functional training and execution of activities within the R&D Product Development & Design Team as needed.
Stay up to date with industry trends, technologies, and regulatory changes relevant to analytical sciences.
Perform other duties as assigned.