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.
This position has primary responsibility for the Vacaville sites MSAT department. The position is responsible for managing the groups responsible for Tech Transfer, MSAT Development Services & Data Servicers and Process Validation. The major responsibility is in deploying Vacaville MSAT organization to achieve the site strategy, providing employee guidance; development and coaching to ensure the teams are supporting the site to deliver on our current contracts and business pursuits.
Leadership & People Management
Foster a high-performing culture by creating an environment of strong team spirit, effective communication, a sense of urgency, and high motivation. Inspire teams to achieve both immediate objectives and long-term goals.
Act as a visible and proactive change leader, promoting adaptability, continuous learning, and an open mindset toward new opportunities and innovative ways of working.
Set and drive strategic direction for the MSAT organization, establishing long-term goals, priorities, and operational objectives in alignment with overall site and business strategy.
Contribute as an active member of the Site Leadership Team, promoting strong collaboration across departments and the global network. Engage in cross-functional planning, decision-making, and communication to ensure alignment on key initiatives, customer delivery, and Lonza's overall business objectives.
Serve as a site leader by championing major initiatives and supporting a strong, positive site culture.
Key Responsibilities
Own the financial health of the MSAT organization, including accountability for budgets, resource planning, and overall financial performance.
Champion safety and compliance, proactively promoting a strong Safety Culture and ensuring adherence to cGMP operational principles across all MSAT activities.
Model and embed Lonza Business Management System (LBMS) principles, fostering a culture of continuous improvement, operational excellence, and standardized ways of working.
Technical Responsibilities
Ensure ongoing Right to Operate by maintaining full compliance with cGMP standards and all applicable regulatory requirements within the department.
Lead and oversee the following functional areas:
MSAT: Provide oversight to ensure manufacturing operations meet license requirements, cGMP standards, and global Health Authority expectations. Represent the state of compliance during Health Authority inspections. Drive continuous process monitoring and implement ongoing process improvements.
Tech Transfer: Collaborate with global and site teams to define, transfer, file, and license new products and processes into the facility. Will run and manage multiple projects concurrently.
Validation: Own, execute, and enhance the site validation program for processes, ensuring full compliance with Quality and Health Authority expectations. Serve as the primary representative for Validation during regulatory inspections.
Manufacturing Support: Deliver technical support to manufacturing, including process and product monitoring, master data and documentation management, quality systems compliance, and readiness activities that ensure successful ongoing operations.
Make-Assess-Release
Support all related activities, including tech transfers and continuous improvement initiatives across the production plant.
Operate as part of a global network by partnering with global MSAT teams and peer sites to share, adopt, and standardize best practices that enhance technical performance across the network.
Collaborate with Program Managers and directly with Customers to ensure projects are appropriately planned, executed, and aligned with customer needs and business goals.
Key Requirements
Minimum 15 years of experience in biotechnology, including expertise in process development, scale-up/manufacturing, and process validation.
Strong technical background across Tech Transfer, Process Support, Data Science, and Process Validation for multiple modalities.
Comprehensive understanding of cGMP requirements and applicable U.S. and EU regulatory frameworks.
Leadership Experience
Proven leadership experience, including direct management of 4-6 leaders and oversight of broader teams of 50+ individuals.
Skilled in portfolio oversight, with the ability to assess project progress, identify risks, and determine when deeper technical investigation is required.
Skills and Qualifications
Strong problem-solving capability, with a track record of mobilizing and motivating teams to deliver high-quality results under challenging circumstances.
Exceptional collaborator and natural networker, able to influence and gain alignment across cross-functional and project teams without formal authority.
Demonstrated ability to foster a culture of innovation, learning, and talent development.
Compensation and Benefits
We recognize that attracting, developing, and retaining the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure that we are able to attract the best candidates.
The quoted salary range for this position is $221,000.00 - $377,000.00.
We use broad salary ranges that reflect the competitive market for similar jobs, provide sufficient opportunity for growth as you gain experience and expand responsibilities, while also allowing for differentiation on performance.
About Lonza
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.
About Lonza
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.