Regulatory Affairs Sr. CMC Manager (Small Molecules)

United States, Bend (Oregon)

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 Pharma & Biotech has an opening for an experienced Senior Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) Manager at their Bend, Oregon site.

Key Responsibilities:

  • Maintain documented regulatory project plans in line with agreed best practice
  • Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the LPBN RA team
  • Provide Regulatory Affairs (RA) CMC advice & expertise for Small Molecule Drug Products (primarily for oral and inhalation)
  • Review and evaluate the regulatory impact of the change requests for the Drug Product manufacturing process incl. technology transfer
  • Review and write chemistry, manufacturing and controls (CMC) documentation appropriate for clinical and commercial applications
  • Submit country-specific health authority supporting documents such as Site Master Files (SMF), Master Batch Records (MBR) and/or executed Batch records on behalf of customers
  • Coordination and drafting of briefing books for scientific meetings
  • Respond to global health authority questions and deficiencies
  • Provide regulatory & strategic guidance (Regulatory Plans) to internal and external customers (for the sites in Bend, Tampa, Visp, Monteggio & Quakertown) as well as internal Lonza maintaining regulatory databases
  • Participate and presents in customer project meetings presenting the Regulatory Affairs capability
  • Interact with the Regulatory Affairs colleagues in other business units such as the Lonza Capsules and Health Ingredients (CHI)  
  • Proactively ensure functional leads are informed of project developments and maintain transparency throughout projects
  • Utilize prior analytical (Quality Control) and/or manufacturing process (Operation) experience to question and propose alternative solutions to challenges by internal and external customers
  • A solution and service minded proactive approach should be applied even with challenging customers

Key Requirements:

  • Bachelor’s Degree
  • Extensive experience in the pharmaceutical/biotechnology industry
  • Strong leadership, writing, and communication/presentation skills are required
  • Must be independent, self-motivated, organized, able to multi-task, and skilled in communication, facilitation, and collaboration
  • Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
  • Successful candidates must be able to learn quickly and work independently in a fast-paced environment
  • Demonstrated balance of collaborative leadership and autonomous problem solving

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: R34009