Director of Biologics Process Development
1 month ago
At Amgen, we're driven by a shared mission to serve patients living with serious illnesses. As a member of our team, you'll contribute to advancing the fight against the world's toughest diseases.
About the RoleWe're seeking a highly skilled and experienced Director of Biologics Process Development to lead our team in the development and advancement of a diverse portfolio of biologic therapeutic molecules. As the primary point of contact with key leadership partners, you'll be responsible for delivering data packages to support therapeutic candidate selection and developing and transferring drug substance processes for clinical manufacturing.
Key Responsibilities- Lead a high-performing team of 20+ staff in Thousand Oaks, CA, comprised of integrated cell culture and purification disciplines.
- Develop staff and manage resource allocation for portfolio advancement and technology development.
- Advance integrated holistic drug substance processes for Amgen's multi-modality portfolio for pre-clinical and clinical development.
- Author or review IND filings and respond to global Regulatory questions.
- Champion the ideation, development, and deployment of differentiating technologies and establish a culture of innovation.
- Contribute to Amgen's external eminence at scientific and regulatory conferences and other industry forums.
- Serve as a member of the Drug Substance Technologies (DST) extended leadership team and contribute to advancing the process development function.
As a valued member of our team, you'll enjoy a comprehensive benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. You'll also have opportunities for career development, flexible work models, and a competitive salary range.
Amgen is an Equal Opportunity employer and welcomes applications from diverse candidates. We're committed to creating an inclusive environment where everyone can thrive and contribute to our mission to serve patients.
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