Director - CMC Leader in Large Molecule Biologics

Welcome to Johnson & Johnson, a leading healthcare company dedicated to improving the lives of people around the world. We are currently seeking a highly qualified Director - CMC Leader in Large Molecule Biologics to join our team.In this role, you will be responsible for leading the Chemistry, Manufacturing, and Controls (CMC) strategy for our large molecule biologics portfolio. This includes overseeing the development, manufacturing, and supply of our novel biologics, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.To excel in this position, you must possess a strong background in biopharmaceutical development and manufacturing, as well as proven leadership skills. Additionally, you should have a deep understanding of regulatory requirements and a track record of successful CMC submissions.If you are a driven and experienced professional looking for a challenging and rewarding opportunity to make a positive impact on global healthcare, we encourage you to apply for this role. Join us in our mission to transform the future of healthcare through innovation and collaboration.

1. Develop and implement the overall CMC strategy for large molecule biologics, aligned with the company's goals and objectives.
2. Oversee the development, manufacturing, and supply of novel biologics, ensuring adherence to timelines, quality standards, and cost targets.
3. Lead and manage a team of scientists and engineers, providing direction, guidance, and support to achieve project goals and objectives.
4. Collaborate with cross-functional teams, including research, clinical, regulatory, and commercial teams, to ensure seamless execution of CMC strategies and activities.
5. Drive continuous improvement initiatives to optimize processes, reduce costs, and improve efficiency in biologics development and manufacturing.
6. Ensure compliance with regulatory requirements, including FDA, EMA, and other global health authorities, for CMC activities and submissions.
7. Stay updated on industry trends, technological advancements, and regulatory changes related to biopharmaceutical development and manufacturing, and incorporate them into the CMC strategy.
8. Prepare and review CMC sections of regulatory submissions, including INDs, BLAs, and other relevant documents.
9. Represent the company in external meetings and conferences, presenting CMC strategies and results to stakeholders and regulatory agencies.
10. Mentor and develop team members, providing coaching and feedback to foster their professional growth and enhance their contribution to the company.
11. Collaborate with global partners and external vendors to ensure timely and quality delivery of CMC activities.
12. Act as a subject matter expert and provide guidance and support to other departments and teams on CMC-related matters.
13. Adhere to company policies, procedures, and ethical standards at all times.
14. Proactively identify and escalate any potential issues or risks that may impact the CMC strategy or project timelines.
15. Continuously monitor and track project progress, budget, and resource allocation, and provide regular updates to senior management.

According to JobzMall, the average salary range for a Director - CMC Leader in Large Molecule Biologics in Malvern, PA 19355, USA is $200,000 - $250,000 per year. This can vary depending on the specific company, experience level, and other factors.

Johnson & Johnson is an investment holding company with interests in health care products. It engages in research and development, manufacture and sale of personal care hygienic products, pharmaceuticals and surgical equipment. The company operates through the following business segments: Consumer, Pharmaceutical and Medical Devices.