Quality Control Supervisor - Cell Therapy
Lonza•Houston, TX
•Onsite
About The Position
The purpose of this role is to supervise Quality Control (QC) operations within the Cell Therapy laboratory, including oversight of personnel, assays, and equipment that support the production, release, and distribution of cell therapy products. This position ensures testing activities are executed in compliance with cGMP requirements and works closely with Quality Assurance and Operations teams to successfully implement client methods and maintain regulatory standards.
Requirements
- Bachelor’s degree in a scientific/STEM field
- 5–10 years of relevant experience in cell therapy or related industry
- Demonstrated knowledge of biological and cell-based assays, d dPCR, ELISA, cell count and viability, complete blood count, and potency/culture assays.
- Experience with document management systems, technical writing, and QC systems such as LIMS, TrackWise, and SAP.
- Proven leadership or supervisory experience overseeing full laboratory operations in a regulated environment.
- Strong understanding of cGMP practices and quality systems in a QC laboratory setting.
- Ability to manage complex tasks, prioritize effectively, and lead teams in a fast-paced environment.
- Strong communication, problem-solving, and cross-functional collaboration skills.
Nice To Haves
- Master’s degree preferred
- Experience with assay qualification, validation, and technology transfer strongly preferred.
- Prior audit support experience (front room/back room) is preferred.
Responsibilities
- Supervise daily operations of the QC Cell Therapy laboratory, including oversight of personnel, assays, and equipment.
- Review laboratory testing and records to ensure accuracy, compliance with cGMP, and adherence to company procedures.
- Lead, coach, and mentor laboratory staff, managing performance, development, and team objectives.
- Develop and monitor QC resource capacity and communicate constraints to management and production planning teams.
- Write, review, and approve SOPs, protocols, sampling plans, and specifications.
- Support and respond to audits, deviations, investigations, CAPAs, and customer complaints, ensuring timely resolution.
- Lead technical investigations and provide guidance to team members in resolving complex quality or operational issues.
- Collaborate cross-functionally with Quality Assurance, Program Management, and Operations teams.
Benefits
- Performance-related bonus
- Medical, dental and vision insurance
- 401(k) matching plan
- Life insurance, as well as short-term and long-term disability insurance
- Employee assistance programs
- Paid time off (PTO)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Manager
