Quality Control Supervisor - Cell Therapy

Quality Supervisor – Cell Therapy Location:   This is an on-site   position   located   in Pearland, TX. Available shift:   AM Shift, Wednesday – Saturday, 6:00 AM – 4:30 PM, supporting Quality Control operations with weekend shift differentials included. The purpose of this role is to supervise Quality Control (QC) operations within the Cell Therapy laboratory, including oversight of personnel,   ass a ys, 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   Ass urance and Operations teams to successfully implement client methods and   maintain   regulatory standards. What you will get: This is a competitive, salaried position. In addition, below you will find a comprehensive summary of the benefits package we offer:

• 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   ass istance   programs.
• Paid time off (PTO).

Compensation

for this role will be   determined   by the candidate’s qualifications, skills, experience, and relevant knowledge. What you will do:

• Supervise daily operations of the QC Cell Therapy laboratory, including oversight of personnel,   ass a ys, 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   Ass urance, Program Management, and Operations teams. What we are looking for:
• Bachelor’s degree in a scientific/STEM field   required ;   Master’s   degree preferred, with 5–10 years of relevant experience in cell therapy or related industry.
• Demonstrated knowledge of biological and cell-based   ass a ys,   d dPCR ,   ELISA, cell count and viability, complete blood count, and potency/culture   ass a ys.
• Experience with   ass a y qualification, validation, and technology transfer   strongly   preferred.
• 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.
• Prior audit support experience (front room/back room) is preferred. About Lonza: At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence,   P ass ion   and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and   that’s   the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If   you’re   ready to help turn our customers’ breakthrough ideas into   viable   therapies, we look forward to welcoming you on board.