Head of Process Development
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
The candidate for this role will be highly experienced in development of manufacturing processes and analytical methods for the production of cell and gene therapy products including viral vectors. Extensive managerial and leadership experience with supervising and providing guidance to a large group of highly technical and scientific group of subject matter experts. The successful candidate should have a good understanding of technical challenges and potential solutions for development of clinical and commercial viral vector manufacturing processes for cell and gene therapy applications. She/he should be able to offer both scientific and management guidance in the design and execution of new or unique cell and gene therapy projects. She/he should be able to manage team resources using established systems, ensures close collaboration between process development and assay / analytical method development teams, support cross-training, and seamless delivery of department goals. She/he should be able to support strong, positive collaboration and relationship with manufacturing, Quality Control (QC), Manufacturing, Science & Technology (MSAT), project management, and cell and gene technologies (C>) business unit as well as Lonza Pharma and Biotech network. She/he should be able to serve as the technical Subject Matter Expert (SME) in clients’ meeting and regulatory audits, supports proposal development for existing and prospective clients in conjunction with sales and business development.
- Leads a team of 25 managers, scientists and research associates focused on the development of viral vector manufacturing process and analytical methods for cell & gene therapy applications.
- Maintains constant emphasis on safety and ensures a safe working environment for self and others.
- Owns the development life cycle for multiple projects in parallel. Understands process development based on good manufacturing practice (GMP) design considerations and at-scale cGMP manufacturing process for clinical and commercial manufacturing.
- Provides technical direction to the project leads and manages technical risks throughout the development and technology transfer process ensuring successful program management and delivery.
- Drives scope definition and experimental design of process development and analytical methods activities through respective project leaders; aligns goals of the projects with overall project plan including process development, tech transfer to QC and manufacturing (MFG); obtains buy-in from client and removes obstacles to successful completion.
- Establishes and executes the detailed development project plan including process and assay transfer, development or optimization, process characterization, assay qualification, assay validation and tech transfer of process to MSAT and assays to QC. Working with the Program manager (PM), engages in supporting other functional groups and departments proactively and manages changes to scope and timeline effectively. Actively drives alignment with PM, QC, and MFG on development targets to ensure appropriate process and assay fits and succeeds in manufacturing and release testing.
- Aligns with global development strategies and keeps the global development department management updated on progress, risks and challenges, and serves as liaison between development staff and other departments.
- Manages department resources using established systems and ensures close collaboration between PD and bio-assay managers and supervisors to support cross-training, dynamic resource management and seamless delivery of department goals.
- Serves as technical SME in clients’ meeting, regulatory audit; 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.
- Continually seeks opportunities to improve client satisfaction while keeping Lonza's interests in clear focus.
- Supervises development labs directly or through team to ensure that they are fully capable, operationally efficient and safe. Pays specific attention to cleaning, safety, 5S 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 development activities and harmonization of global PD and Bio-assay initiatives.
- Identifies and escalates development risks to upper management; prepares project progress summaries appropriate for management / client review. Prepares and/or reviews development team presentations, bio-assay protocols and reports and provides constructive feedback to address the gaps and risks.
- Develops and implements departmental SOP’s, DMR’s, labels, PQA documents, written materials.
- Develops strong connections within the Lonza network, contributes proactively to global projects and is known as an industry expert in area of specialty.
- Master's Degree or PhD in a life science discipline with extensive experience with analytical method development for cell and gene therapy related topics
- Multiple years of previous supervisory experience with strong team leadership and interpersonal skills.
- Extensive experience with development of viral vector manufacturing process including upstream, downstream, and analytical methods implementation.
- Solid knowledge and understanding of current cells and gene therapy applications, challenges, and strong desire and expertise in developing new innovative technologies to address those challenges.
- Substantial interest in preparing service proposals for potential customers and managing a service portfolio.
- Experience in working with clients and managing customer projects.
- Strong track record of translating new product ideas into project plans and executing them by assigning resources as well as tracking project progress toward milestones and deadlines.
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.