Process Development Manager

United States, Houston (Texas)

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.

Process Development Manager will manage and direct all work activities for Process Development (PD) laboratory and client related projects in the PD department.  He/She will supervise daily and routine lab duties to ensure that client requirements are met and company profits are considered.  They will also maintain the process development laboratory within the requirements of Lonza standard regulations. 

Key responsibilities:

  • Maintain constant emphasis on safety and ensures a safe working environment for self and others.

  • Owns the development lifecycle for multiple projects in parallel; providing 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 MSAT, manufacturing (MFG) and Quality Control (QC), obtains buy-in from client and removes obstacles to successful completion.

  • Establish and executes the detailed development project plan including process development and Bioassay activities from process / assay transfer, optimization, qualification, and tech transfer.

  • Working with the Program Management team, engage supporting departments proactively and managing changes to scope and timeline effectively.

  • Actively drives alignment with Manufacturing Science and Technology (MSAT) and Manufacturing (MFG)  on process development targets to ensure appropriate process fit and success in manufacturing.

  • Drives alignment with Quality Control (QC) on analytical methods deliverables to ensure fit for purpose and successful deployment in QC.

  • 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.

  • Supports the Development, Operations, and Site management to implement standard processes and new initiatives that helps addressing quality, safety, and operations challenges.  

  • 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. 

  • 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.

  • Develops strong connections within the Lonza network, contributes proactively to global projects and is known as an industry expert in area of specialty.

  • Focuses on increasing Lonza's presence in the Cell and Gene Therapy industry through conference presentations, seminars.

Key requirements:

  • PhD Degree in Life Sciences or related discipline plus 5 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, 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.

  • Cell culture experience

  • Time Management skills; facilitation skills; delegation skills; computer software skills (specifically databases, Microsoft Office, Adobe Photoshop); organization, record keeping and planning skills; training skills; ability to manage multiple projects; time management skills.

  • Excellent oral and written communication skills, across all levels of the organization and ability to authoritatively discuss technical issues with internal and customer experts. Prior experience in an external customer facing role is highly desirable.

  • Energetic and personable, organized, self-motivated, and capable of working independently, and as part of closely knit teams.

  • Comfortable handling rapidly changing priorities common to a contract manufacturing environment.

  • 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. 

Reference: R32543
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