Sr Director, External Process Development, new modalities , will lead a team responsible for process development at CDMOs along with technical oversight of clinical manufacturing for products developed outside of the Alexion internal lab network. Additionally, this role will be the point person for business development projects and evaluation and integration of new technologies into the Alexion network.
Job Duties and Responsibilities
- Ensure Contract Development and Manufacturing Organizations (CDMOs) develop a scalable process, and produce high quality product for clinical trials by providing oversight through process and analytical development and tech transfer
- Actively manage CDMOs network to develop process to supply material for different phases of clinical development
- Oversee technology transfer between process development labs, and from process development to manufacturing
- Ensure phase-appropriate process development, with an appreciation of late-stage manufacturing, including process characterization and process validation activities
- Performs other related duties include ad hoc projects as required by position
- Participate in business development projects
- Integrate business development assets into the Global Product Development organization at Alexion
Essential Qualifications
- PhD with 10+ years of relevant experience working in biologics or cell and gene therapy process development and/or analytical development in the Pharmaceutical/biotech industry
- In-depth technical and regulatory understanding biologics and cell/gene therapy drug development to support Phase I clinical trial, as well as late-stage development through commercialization
- Proven leadership experience and people management skills with the desire and ability to work in a fast-paced environment
- Strong collaboration and team-building, communication, and organizational skills required
- Experience working with and managing third party contractors and vendors
- Excellent written and verbal communication skills
- Excellent communication, technical, and organizational skills are required
- Must be a team player prepared to work in, and embrace a team-based culture
- Proven leadership skills
Preferred Qualifications
- Working knowledge CMC requirements for multiple therapeutic modalities is prefered
*LI-DI1
New Haven, CT, United States
Some opportunities happen only once in a lifetime – like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
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