Analytical Senior Scientist II

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

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.

Role Responsibilities

• 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.
  
  

Basic Qualifications

• 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.
  
  

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

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer

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.

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