Global Technical & CMC – Upstream Development

United States, Hayward (California)
United States, Portsmouth (New Hampshire)

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.

CMC (Chemistry Manufacturing and Controls) Director of Upstream Development  will provide scientific and technical leadership. Will also translate the market technology trends and needs to identify gaps in Lonza services. CMC Director will offer leverage and deep technical understanding to benefit customers and Lonza. By doing this they will set the strategic vision and influences the network direction within complex protein programs and offering alongside operational and commercial teams.

Key responsibilities:

  • Provide in-depth scientific and technical leadership to support LPBN network with scientific guidance on upstream development to support Proposals and Sales teams to maximize the win rate of Complex Protein proposals for Cell Line Constructions and Drop-In projects.

  • Provide technical CMC direction directly to Customers in a 1:1 setting, within the customer project team and at steering committee level to overcome or foresee any challenges to the programs.

  • Identify and forecast trends in customer expectations and new technologies to support the technical strategy for R&D and Operations.

  • Expand Technical program understanding and expertise. Nurture existing lab scientists and junior SMEs and lead the implementation of sustainable development & training programs.

  • Showcase and promote Lonza’s technical capabilities, thought leadership and expertise externally at conferences, meetings or webinars.

  • Champion systems improvements by supporting the definition of data sources, collection methods, analysis and definition of key knowledge areas critical to successful future decision making for complex protein projects.

Key requirements:

  • Degree in MSc Or PhD of Biological science or Biochemical Engineering

  • Highly experience in pre-clinical development, Mammalian cell culture development of novel bioreactor processes (Beacon, Ambr technology, 10L bioreactors and 50L SUBs) and primary recovery for new molecular formats, complex proteins and/or recombinant proteins in the early development and lab scale environments

  • Extensive experience with demonstrable track record in a biopharm/biotech company, or equivalent organization.

  • Proven reputation in outside world (scientific, regulatory, IP/legal)

  • Experience in guiding and coaching customers and/or internal CMC teams

  • Able to communicate effectively at all levels (from scientist to global leaders)

  • Influential, confident, respected across the process development network, able to build consensus

  • Ability to communicate effectively and at all levels within an organization – be highly skilled at influencing others

  • Excellent natural coaching and people leadership skills

  • Results-driven and proactive in mindset

  • Ability to work independently and in a team environment.

  • Ability to manage multiple priorities in a fast paced, pressured environment.

  • Ability to manage within a matrix management system to achieve successful outcomes for the assigned tasks within the task force team

  • Global focus & well-developed networking within Lonza network, connection to other sites within Mammalian and Drug Product Services

  • Experienced with CMC requirements and how these are satisfied.

  • Understands Lonza’s strengths and weaknesses relating to the upstream processes and systems that the business operates.

  • Has excellent understanding of a typical gene to IND project in complex proteins, has direct experience of working to support project teams deal with challenges in delivering for customers.

  • Proven ability in dealing with uncertainty and working outside scientific comfort zone

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: R32054
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