Manager, Development Services
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.
Owns the development lifecycle and project plan for multiple projects. Manages and directs all work activities for Process Development and Bioassay Services and client related projects in the Cell and Gene Therapy (CGT) Development department. Supervises daily routine lab duties to ensure that client requirements are met and company profits are considered. Maintains the laboratory within the requirements of Lonza standard regulations. Maintains appropriate documentation for developmental projects.
Leads a team of 3 to 7 Research Associates and Scientists for the development of processes and/or analytical methods for contract CGT manufacturing.
Maintains constant emphasis on safety and ensures a safe working environment for self and others.
Owns the development lifecycle for multiple projects in parallel; provides technical direction to the project leads and manages technical risks throughout the development and technology transfer process ensuring successful program delivery.
Drives scope definition and experimental design of development activities (process development and bioassay) through respective project leaders, aligns goals of the project with Manufacturing Scientist and Technology (MSAT), manufacturing (MFG) and Quality Control (QC), obtains buy-in from client and removes obstacles to successful completion.
Establishes and executes the detailed development project plan including process development and Bioassay activities from process/assay transfer, optimization, qualification, and tech transfer.
Work with the Program Managers, engages supporting departments proactively and manages changes to scope and timeline effectively.
Actively drives alignment with MSAT and MFG on process development targets to ensure appropriate process fit and success in manufacturing.
Drives alignment with QC on analytical methods deliverables to ensure fit for purpose and successful deployment in QC.
Keeps project manager updated on progress and challenges, and serves as liaison between development staff and other departments.
Manages team resources using established systems and ensures close collaboration with other Development Managers to support cross-training, dynamic resource management and seamless delivery of department goals.
Serves as technical SME in client/regulatory audits, supports proposal development for existing and prospective clients in conjunction with sales and business development.
Develops and mentors direct reports through challenging assignments and providing constructive feedback, goal setting and monitoring performance on a routine basis (via formal and informal channels), and ensuring that overall project goals are on track.
Develops and maintains strong client connections founded on technical leadership, strong execution and solid communication.
Continually seeks opportunities to improve client satisfaction while keeping Lonza's interests in clear focus.
Supervises process development/bioassay services labs directly or through team to ensure that they are fully capable, operationally efficient and safe. Pays specific attention to cleaning, safety, 6S and EPS compliance.
Proactively and independently works with other managers and department heads to resolve conflicts or gain alignment prior to escalation.
Owns and drives the implementation of standard work and global best practices
Identifies and escalates process risks, prepares project progress summaries appropriate for management / client review. Prepares and reviews presentations, protocols, PD reports and Analytical Development reports.
Develops and implements departmental SOP’s and production batch records and non-GMP / relevant documents. Understand at-scale cGMP manufacturing process and constraints to develop principles for process and analytical development in the lab and successful transfer.
Focuses on increasing Lonza's presence in the Cell Therapy/Viral Vector industry through conference presentations, seminars.
Master's Degree in a life science discipline with 8-10 years including 1-2 years supervisory experience, PhD Degree in Life Sciences or related discipline plus 4-6 years of related laboratory experience, including 1-2 years supervisory experience. (Years of experience may substitute for education in some instances).
Knowledge of biology, bioengineering, chemistry, statistical analysis, technical writing.
Knowledge of basic specialized laboratory equipment including laminar flow hoods, centrifuges, spectrophotometers, analytical instrumentation, purification systems, cell culture systems, incubators, fluorescent and phase contrast/bright field microscopes and microphotography equipment.
Knowledge of Cell Biology and anatomy, cell culture, bioreactors.
Strong knowledge of cGMP, aseptic techniques and auditing techniques.
Strong knowledge of assay qualification and validation requirements and strategies.
Cell culture experience
Diplomacy and negotiation skills; written and oral communication skills; team building skills; independent work skills; coaching and delegating skills, strong work ethic.
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.