Manager, QC

Lonza•Houston, TX

4d•Onsite

About The Position

Lonza is a global leader in life sciences operating across three continents. The company is seeking an experienced Manager QC to join their team in Houston, Texas. This role involves supervising staff, overseeing operations and product development procedures to ensure products meet quality and efficiency standards, and working with clients to ensure in-process testing and final drug product meet their needs. The position is responsible for the supervision of the Cell Therapy lab and acts as an advisor to subordinates on scheduling and technical problem-solving.

Requirements

Bachelor degree, or foreign equivalent degree, in Chemical Engineering, Life Sciences, or Biology and 7 years of progressive, post-baccalaureate experience in the job offered, or 7 years of progressive, post-baccalaureate experience in a related occupation
Applying experience in quality control
Applying experience in leadership/management
Applying experience with method validation and technology transfer
Applying knowledge in biological and cell based assays including flow cytometry and PCR
Developing training plans and performing identification and remediation of training gaps
Utilizing spreadsheets, databases, and word processing software
Developing goals and objectives for team and /or projects
Performing assays in support of the production, release, and distribution of cell therapy and gene therapy products
Applying knowledge of ICH Q2 (R1), 21 CFR Part 11 and USP <1225> guidelines to support assay optimization, assay qualification, and assay validation of the cell therapy and gene therapy products
Alternatively, a Master’s degree, or foreign equivalent degree, in Chemical Engineering, Life Sciences, or Biology and 5 years of experience in the job offered, or 5 years of experience in a related occupation
Applying experience in quality control
Applying experience in leadership/management
Applying experience with method validation and technology transfer
Applying knowledge in biological and cell based assays including flow cytometry and PCR
Developing training plans and performing identification and remediation of training gaps
Utilizing spreadsheets, databases, and word processing software
Developing goals and objectives for team and /or projects
Performing assays in support of the production, release, and distribution of cell therapy and gene therapy products
Applying knowledge of ICH Q2 (R1), 21 CFR Part 11 and USP <1225> guidelines to support assay optimization, assay qualification, and assay validation of the cell therapy and gene therapy products

Responsibilities

Supervise staff and oversee operation and product development procedures to ensure that products meet quality and efficiency standards.
Work with clients to ensure the in-process testing and final drug product meet their needs and requirements.
Responsible for supervision of the Cell Therapy lab.
Act as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems.
Review testing and laboratory records for accuracy and compliance with cGMP and Lonza policies and principles.
Develop and maintain a tool for monitoring QC resource capacity.
Provide feedback to QC management and production planners when capacity constraints exist.
Collaborate with QC Technical Services group, Bio Analytical Services team, MSAT, and program management to drive technical transfer, staff training, and assay qualification/validation activities.
Lead, mentor, and coach staff through routine one-on-one meetings, team meetings, and effective performance management.
Set and deliver on individual and team goals that support the department and site strategy.
Take personal accountability for both his/her own and the team’s actions.
Write, review, and/or approve SOPs, sampling plans, protocols, and specifications.
Prepare responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
Work to ensure responses are completed on-time.
Escalate roadblocks to completion and provide potential solutions.
Ensure adherence to relevant regulations, standards, and company policies, as well as legal and environmental requirements.
Lead and mentor others with technical investigations.
Prepare project plans, write status reports, and give oral presentations to customers and management.
Gain feedback from the clients, attending meetings, submitting reports, and assisting external auditors and inspectors.
Provide technical review of Statements of Work (SOWs) to support contract manufacturing activities.
Prepare monthly management reports including budget analysis and project updates.
Actively monitor spending for area.
Predict and escalate potential spending variances.
Identify corrective actions for spending variances.
Develop and monitor team performance measures to understand effectiveness, efficiency, and quality of group performance.
Responsible for cost center budget development and monitoring and escalation of variances.
Collect, analyze, and report on quality data to identify trends, areas for improvement, and performance metrics using LIMS.
Train staff on quality control procedures, supervise quality control personnel, and foster a culture of quality within the team.
Perform other duties as assigned.
Oversee two Supervisor, QC and two QC Lead.