Confidential
Executive Director or Vice President, Commercial CMC
Confidential, San Jose, California, United States, 95199
Executive Director or Vice President, Commercial CMC
About the Company
Industry leading open-access biologics technology platform
Industry
Pharmaceuticals
Type
Public Company
Founded
2015
Employees
10,001+
Categories
Pharmaceuticals
Manufacturing
Medicine
Chemical Products
Information Technology & Services
Technology
Specialties biologics conjugation bioprocess cmc biosafety biologics gmp manufacturing biologics discovery service cell line development formulation development analytical characterization cell culture and purification process development monoclonal antibodies (mabs) vaccine development vaccine manufacturing antibody discovery antibody manufacturing protein production analytical services biotherapeutics biopharmaceuticals and continuous manufacturing
About the Role The Company is seeking an Executive Director or Vice President for North America Commercial CMC. This leadership role is pivotal in overseeing the strategic and operational aspects of CMC, ensuring the successful commercial development, validation, and commercialization of large molecules while maintaining regulatory compliance and industry standards. The successful candidate will be responsible for leading and developing commercial CMC teams, driving business strategies, and managing client relationships. A strong background in CMO and external contract manufacturing, as well as experience in late-stage and commercial development of biologics, is essential. The role also involves cross-functional collaboration, continuous improvement, and staying abreast of industry trends to guide decision-making.
Candidates for this position should have a degree in a relevant scientific discipline, with a PhD strongly preferred, and at least 15 years' experience in large pharma and CMOs. Technical proficiency in CMC development and manufacturing, regulatory expertise, and a proven track record in managing large molecules, supply chain, and contractor management are required. The ideal candidate will have a strategic mindset, be adept at problem-solving, and have a history of delivering results in a fast-paced environment. Leadership skills, including the ability to inspire a culture of collaboration and high performance, and excellent communication and interpersonal skills are also key qualifications for this role. Hiring Manager Title SVP, Head of Global CMC Travel Percent Less than 10% Functions CEO/President Non-Profit Management Business Development Operations Strategy
Specialties biologics conjugation bioprocess cmc biosafety biologics gmp manufacturing biologics discovery service cell line development formulation development analytical characterization cell culture and purification process development monoclonal antibodies (mabs) vaccine development vaccine manufacturing antibody discovery antibody manufacturing protein production analytical services biotherapeutics biopharmaceuticals and continuous manufacturing
About the Role The Company is seeking an Executive Director or Vice President for North America Commercial CMC. This leadership role is pivotal in overseeing the strategic and operational aspects of CMC, ensuring the successful commercial development, validation, and commercialization of large molecules while maintaining regulatory compliance and industry standards. The successful candidate will be responsible for leading and developing commercial CMC teams, driving business strategies, and managing client relationships. A strong background in CMO and external contract manufacturing, as well as experience in late-stage and commercial development of biologics, is essential. The role also involves cross-functional collaboration, continuous improvement, and staying abreast of industry trends to guide decision-making.
Candidates for this position should have a degree in a relevant scientific discipline, with a PhD strongly preferred, and at least 15 years' experience in large pharma and CMOs. Technical proficiency in CMC development and manufacturing, regulatory expertise, and a proven track record in managing large molecules, supply chain, and contractor management are required. The ideal candidate will have a strategic mindset, be adept at problem-solving, and have a history of delivering results in a fast-paced environment. Leadership skills, including the ability to inspire a culture of collaboration and high performance, and excellent communication and interpersonal skills are also key qualifications for this role. Hiring Manager Title SVP, Head of Global CMC Travel Percent Less than 10% Functions CEO/President Non-Profit Management Business Development Operations Strategy