Analytical Senior Scientist II

Kindeva Drug Delivery-posted 3 days ago

Full-time • Mid Level

Onsite • Lexington, KY

1,001-5,000 employees

Resume

Match Score

Upload and Match ResumeTrack Jobs with Teal

The Analytical Senior Scientist II will be a technical leader within the R&D Product Development and Design group. In this advanced technical role, you will lead complex analytical projects across multiple drug development stages—ranging from preclinical through commercial. You will serve as a key scientific leader, driving the development, validation, and lifecycle management of analytical methods, contributing directly to CMC strategies, and supporting regulatory filings. This role requires strong technical expertise, deep knowledge of regulatory expectations, and the ability to mentor teams, troubleshoot complex problems, and drive innovation across internal and customer projects.

Lead the development, optimization, and validation of robust analytical methods for drug substances, components and drug products in accordance with ICH, USP, and regulatory guidelines.
Design and execute complex analytical studies to support formulation development, process development, and customer projects.
Author and review technical documents, including method validation protocols and reports, specifications, analytical development reports, and documents that support regulatory submissions (IND, NDA, ANDA, BLA).
Mentor and provide technical oversight to junior Analytical scientists and analysts, ensuring scientific rigor and compliance with quality standards.
Prepare and maintain accurate and timely laboratory records in accordance with company policies and regulatory requirements.
Act as a subject matter expert (SME) for analytical technologies, method troubleshooting, customer audits and regulatory inspections.
Collaborate cross-functionally with formulation, process development, quality assurance, regulatory affairs and customers to ensure timely and successful product development.
Lead or support technology transfer of analytical methods to internal or external laboratories.
Contribute to continuous improvement initiatives and innovation within the Analytical Laboratory Operations department.
Stay current with advancements in analytical 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
Support qualification of new analytical laboratory equipment
Utilize creative thinking to generate solutions to complex technical problems
Represents function in project meetings and customer meetings with limited support.
Support Marketing and Business Development by identifying opportunities to highlight Kindeva capabilities to the industry via blogs, white papers, posters, presentations, etc. May be required to travel to attend/present at industry conferences.
Cross-functional training and execution of activities within the R&D Product Development & Design Team as needed.
Other duties as assigned.

Degree in scientific field: PhD with 5+ years’ experience, with MS with 7+ years’ experience, BS with 10+ years’ experience or 13+ years’ experience without Bachelor’s degree.
Advanced knowledge and hands-on experience with analytical instrumentation and techniques: HPLC/UPLC, GC, MS, UV, FTIR, Spray testing, Karl Fischer, etc.
Deep understanding of analytical method validation and transfer processes in GMP environments.
Familiarity with regulatory guidelines (ICH, FDA, EMA) and CMC requirements.
Proven ability to lead analytical projects and mentor junior staff.
Strong organizational and project management skills.
Excellent written and oral communication, with experience contributing to regulatory filings.
Ability to work collaboratively in a matrixed and fast-paced environment.

Track Jobs with Teal

Job Search Resources

•

Resume Builder

•

Resume Examples

•

Cover Letter Examples

Analytical Senior Scientist II

Job Search Resources

Tools

Career Hubs

Guides

Company