Location: Hayward,CA, USA
Following our agreement with Roche to acquire the Vacaville manufacturing facility, we are now looking to recruit an Associate Director CMC Regulatory Affairs for the Vacaville site!
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.
The Head of CMC Regulatory Affairs / Associate Director will lead the site Regulatory Affairs function and customer-related RA CMC compliance activities.
Work collaboratively with company personnel to coordinate the regulatory work stream elements for RA CMC compliance and/or RA CMC writing and review activities for Lonza Biologics Manufacturing customers.
Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions. Mentor, coach, and line manage direct reports.
Key Responsibilities:
Key Requirements:
This position is contingent upon Lonza's successful completion of the acquisition of the site located in Vacaville, California (the “Closing”), currently anticipated to occur in H2, 2024. If the Closing is delayed for any reason, Lonza may delay the start date up to sixty (60) days.
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.
The full-time base annual salary for this position is expected to range between $185,400.00 and $260,000.00. Compensation for the role will depend on a number of factors, including the successful candidate's qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.
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.
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