Method Validation Jobs in Texas (NOW HIRING)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

Lonza is currently seeking an experienced Manager QC to join their team in Houston, Texas.

POSITION: Manager QC

JOB LOCATION: 14905 Kirby Drive, Houston, Texas 77047

DUTIES: 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. Apply experience in quality control. Apply experience in leadership/management. Apply experience with method validation and technology transfer. Apply knowledge in biological and cell based assays including flow cytometry and PCR. Develop training plans and perform identification and remediation of training gaps. Utilize spreadsheets, databases, and word processing software. Develop goals and objectives for team and/or projects. Perform assays in support of the production, release, and distribution of cell therapy and gene therapy products. Apply 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. Oversee two Supervisor, QC and two QC Lead.

MINIMUM REQUIREMENTS: Requires a 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, the employer will accept 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; and 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.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.