Manufacturing and Production
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Vice President of CMC
Morrisville, NC 27560 United States
We offer a competitive compensation and benefits package
Manufacturing and Production
Shattuck Labs is developing a breakthrough platform for immunotherapy, which harnesses the human immune system to improve survival for patients battling cancer and inflammatory disease. Shattuck’s proprietary technology represents the next evolutionary step in cancer therapy by endowing one molecule with multiple functions with applicability across the entire spectrum of human disease. Specifically, Shattuck is developing novel fusion proteins for cancer immunotherapy and other disease areas. These biologic molecules are all first-in-class compounds, which are currently being manufactured for the first time. Shattuck Labs, based in Austin, Texas, is a privately-held biotechnology company founded in 2016. The R&D hub for Shattuck Labs is based in Research Triangle Park, NC.
Responsible for leading the process development function, which includes design and scale-up processes from pre-clinical through to clinical development and clinical drug supply. Oversees design, development, implementation, execution and maintenance of process methods, cell line development, upstream and downstream method development and product supply to ensure efficiency, cost effectiveness and improved product quality. Ensures development processes comply with regulatory requirements to minimize risk to the organization. Addresses the analysis and evaluation of process development procedures and practices to ensure compliance with regulatory, legal and good manufacturing procedures to attain corporate goals.
• Plans and oversees manufacturing process development and technology transfer activities at third party laboratories and facilities from pre-clinical to clinical development.
• Identify and build productive relationships with strategic external collaborators/contractors. Provide technical input and guidance to the CMC team and CMOs in problem solving and issue resolution.
• Responsible for the phase appropriate relevant sections of IND/NDA’s and other regulatory filings: author and deliver high quality CMC documentation to meet global regulatory expectations.
• Remains flexible to learning and implementing new and non-traditional methods of biologic manufacturing. Capable of establishing a network of experts to help guide development.
• Works closely and supports other functions including pharmaceutical development, analytical development, commercial manufacturing and supply chain to advance Shattuck’s growing pipeline
• Leads technical development teams, e.g. tech transfer teams or CMC teams
• Actively leads and contributes to CMC teams, and ensures alignment of process development and tech transfer activities within CMC and program development plans
• Actively communicates, collaborates with and contributes to other functional areas and drives to achieve the best development and business results of the company
• Define the requirements of robust lab-scale data to facilitate successful scale-up and large-scale process design
• Effectively communicate fermentation and process chemistry capabilities, contributions and gaps to internal stakeholders and external contractors, partners and investors.
• Ensure commercial readiness at CMOs
• Prepare budgets, working with team members and leadership team. Negotiate cost and oversee expenses with CROs
• Build and lead a team to support development of Shattuck’s growing pipeline
• Effectively manage third-party vendors to keep them on-track and on-budget
The successful candidate has a broad understanding of chemical process and analytical development, and a proven track record solving complex technical and scientific issues. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent leadership, communication and collaboration skills in a cross-functional, multi-faceted environment; as well as a proven ability to achieve results in a virtual setting with external laboratories and manufacturing facilities are a must.
Other requirements are:
• Advanced degree in Chemistry, Chemical Engineering or related field, Ph.D. preferred
• 10+ years relevant CMC development experience in the biopharmaceutical/biotech industry; hands-on experience and knowledge of the entire CMC development process (cell line development, upstream development, downstream and analytical method development) with biologic products
• Experience in manufacture of fusion proteins is highly desired
• Excellent knowledge of cGMP and GLP
• Experience in writing regulatory documents and submissions, interactions and negotiations with Regulatory Agencies especially the U.S. FDA CBER and EMA.
• Strategic view and leadership abilities as well as hands on problem solving skills
• Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies (up to 20% travel)
• Experienced in developing of clear business cases, including process economic models to support process development and engineering activities, timeline and capital investment
• Expertise in a range of process technologies, process simulation, purification, equipment design and process engineering calculations
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excitement about the vision and mission of Shattuck Labs
North Carolina Biotechnology Center