Stability Team Lead
About The Position
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.Why Kindeva? Purpose-driven work environment Significant growth potential Collaborative team culture Direct impact on patient care Industry-leading innovation At Kindeva – Lexington, KY, we’re not just testing products – we’re ensuring the safety and quality of nasal spray medications that make a difference. The Impact You Will Make: Lead Stability Programs That Protect Patients WorldwideJoin a rapidly expanding pharmaceutical CDMO where your leadership directly impacts patient health outcomes. Kindeva offers a rewarding and fast-paced cGMP pharmaceutical environment where your work ensures the integrity, compliance, and scientific rigor of stability programs supporting life-saving drug products. Growth Opportunity Our Lexington facility is experiencing exponential growth, offering exceptional opportunities for professional development and advancement. Join us during this exciting expansion phase and grow your career while contributing to meaningful healthcare solutions.
Requirements
- Bachelor’s degree in Chemistry or related field with at least 5 years of pharmaceutical industry experience; direct stability coordination experience may be considered in lieu of total years of experience
- Knowledgeable in ICH guidelines: Stability and Impurities
- Sound understanding of chromatography and degradation products testing
- Ability to multitask and adjust priorities
- Strong organizational skills
- Qualified to work with controlled substances
Responsibilities
- Lead and manage all QC stability programs in compliance with cGMP, SOPs, and ICH guidelines
- Oversee stability study design, initiation, maintenance, and execution, including protocols, sample pulls, testing, and reporting
- Ensure stability chambers are properly maintained, calibrated, qualified, and utilized efficiently
- Review stability data, identify OOS/OOT results, and lead or support investigations as required
- Author, revise, and approve stability-related SOPs, protocols, and reports
- Perform data trending and interpretation of degradation and stability results
- Train and mentor team members on stability-related activities and best practices
- Serve as a client-facing subject matter expert for stability programs
- Drive continuous improvement initiatives to enhance stability operations and compliance
- Manage multiple projects and priorities to meet internal and client timelines
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
