Join our dynamic team and play a vital role in delivering life-changing therapies!
Location: St. Louis, Missouri
Onsite role Drug Substance site
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Alongside clinical research through our PPD clinical research portfolio, our work in evidence-based solutions specializes in generating the evidence needed to optimize the commercial potential of our biopharma and biotech customers' products. Your determination to demonstrate effectiveness, safety and the value of these products will improve health outcomes that people and communities depend on now and in the future.
Discover Impactful Work:
In this position, you will play a critical role in ensuring our St. Louis Biologics site remains a trusted CDMO partner by delivering regulatory excellence, proactive risk management, and seamless support for sponsor interactions with FDA and international regulatory agencies. Your work will be essential to maintaining compliance and advancing our Mission to enable our customers to make the world healthier, cleaner, and safer. This role offers the opportunity to shape regulatory strategy within a dynamic CDMO environment, engage with complex global initiatives, and drive high-visibility, cross-functional impact across the organization.
We are seeking a strong regulatory leader with demonstrated experience supporting biologic programs, bringing deep expertise in navigating complex global regulatory requirements within a cGMP manufacturing environment.
A Day in the Life:
Keys to Success:
Education:
Experience:
Knowledge, Skills, Abilities:
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Other:
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