Stability Team Lead
Listed on 2026-03-12
-
Quality Assurance - QA/QC
Quality Engineering
Posted Saturday 24 January 2026 at 05:00
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
OverviewAt 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 Worldwide. Join 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.
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.
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
- 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
- Employee is required to regularly use hands in order to handle materials and supplies
- Employee is required to use computers for an extended period each day
- Employee is required to effectively use electronic communication
- Employee is required to regularly stand and walk for extended periods of time
- Employee must occasionally lift and/or move up to 20 pounds
- Ability to use proper PPE and be conscious of the work area hazards
- Employee is required to follow all site safety procedures
Note:
Please replace any remaining emphasis with plain text for accessibility. Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.
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.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).