Associate Director, Therapeutic Development
3 days ago
Johnson & Johnson is seeking an Associate Director, Therapeutic Development & Supply API to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.
Key Responsibilities:- Provide process and technical leadership on how current & future Drug Substance Manufacturing Process Development and Biotherapeutics Platform will influence large molecule manufacturing during detailed design future proofing the facility for new products in the pipeline
- Responsibilities for building out a process support lab and standing up of a team to support start up activities and future technical transfer support
- Responsibilities for building out a team to support NPI & Clinical programs which will be introduced to the facility post start up
- Support operation readiness lead with detailed planning of the back-end schedule including identifying opportunities to re-risk the schedule and support facility start up
- Assisting in manufacturing investigations as required
- A minimum of 8 years of relevant experience
- A minimum of Master of Science in Biology, Pharmacy, Bioprocess Engineering or similar field
- Advanced proficiency in English speaking, reading, and writing
- Ability to speak clearly and exercise good judgment
- Track record of developing and maintaining strong partnerships at all levels within the organization
- Ability to lead and motivate multicultural teams and engage remote stakeholders
- Process-oriented and strong process knowledge in large molecule process development and/or manufacturing
- Excellent problem-solving skills when managing potential conflicts within the local context, while implementing global standards and guidelines
- Understanding complex technical/regulatory issues impacting products
- Experience of supporting capital projects in the range of 100 – 200 MM$ is a plus
- Working knowledge of GMP's and Regulatory standards for Healthcare Supply Chains
- Working knowledge of Large Molecule BioProcess Engineering and Scale up Principles
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