5 director commercial manufacturing validation jobs found in Madison, WI

Manager - Process Development, Downstream Position Summary: Work Schedule: M-F 8am-5pm 100% on-site Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's. Catalent Pharma Solutions in Madison, WI is hiring a Manager - Process Development, Downstream. We are seeking an experienced Downstream Process Development Manager to lead late-stage process development and process...

The SR, Packaging Engineer position typically reports to a senior leader in the Packaging and Device Technology department. The Senior Packaging Engineer is a technical resource responsible for assisting in the day-to-day operations ensuring the timely packaging of OAPI's products. The position's key responsibilities include the package and device development, component specifications and graphic arts related activities utilized in OAPI's product portfolio. This position is as an individual contributor role under general direction from his/her supervisor. The individual must have experience in managing complex multiple projects simultaneously involving both internal and external team members. The position requires interfacing with various company entities including but not limited OPCJ, OPDC, and OCPI teams to provide support for packaging processes for new and life cycle products and devices. The position requires an individual who has sufficient knowledge and experience...

Senior Manager - Biologics Drug Product Development (Formulation & Filling) To support our rapidly expanding biologics portfolio of assets, we are seeking a highly skilled technical leader to join our Biologics Drug Product Development team with a primary focus on formulation development and aseptic filling process development for clinical and commercial programs. In addition to hands-on experience, the ideal candidate will have experience partnering with and providing scientific guidance to external contract research, development and manufacturing organizations. This role will lead formulation design and characterization for parenteral biologics (e.g., mAbs, recombinant proteins, novel biologics modalities) and develop/scale automated filling processes across vials and prefilled syringes. Experience with lyophilization is optional but will strengthen the applicant's candidacy. The ideal candidate combines deep understanding of protein/excipient interactions and...

Manager, Quality and Compliance Position Summary: Work Schedule: M-F 8am-5pm 100% on-site Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. Catalent Pharma Solutions in Madison, WI is hiring a Manager, Quality and Compliance. The Quality Assurance department is...

Manager, Quality and Compliance Position Summary: Work Schedule: M-F 8am-5pm 100% on-site Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. Catalent Pharma Solutions in Madison, WI is hiring a Manager, Quality and Compliance. The Quality Assurance department is...