The Catalent site in Madison, is an established Contract Development and Manufacturing Organization (CDMO) with a large international client base. Programs offered include cell line engineering and development, upstream and downstream process development, analytical method development, scale-up, tech transfer, pre-clinical and clinical manufacturing for a wide range of biologics, with a focus on mono-clonal antibodies. The facility is moving into late phase clinical and commercial manufacturing.
As a fast-growing and strategically important site, there are several key strategic programs that require significant industry experience and advanced leadership skills.
This position is responsible for providing leadership, direction, organization, management, execution, monitoring and completion of important strategic programs. The position will serve as a member of the site leadership team and will also provide back-up coverage to other key operations' leadership positions. This position will drive the growth of the site though identification and implementation of strategic programs aimed at ensuring long term viable growth, staying up to date on trends in biologics, and coordination between sites to ensure seamless execution for our clients.
- Directs and/or manages all assigned strategic programs on-schedule and within quality standards and cost objectives.
- Assigned Strategic Programs will include, but are not limited to:
- Commercial Readiness Program (oversee and co-ordinate all the workstreams associated with preparing the site to be ready to execute cGMP commercial bulk drug substance manufacturing
- Lead the Commercial Change Management Program to transition the site culture from development and clinical manufacturing, to a culture that includes commercial manufacturing
- Partner with Business Development to identify and secure commercial manufacturing programs for the site
- Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state and local regulations. Consults with Human Resources Department as appropriate.
- Informs personnel of communications, decisions, policies and all matters that affect their performance and results.
- Assists General Manager in the development and formulation of long and short-range planning, policies, programs and objectives related to site operations.
- Formulates, recommends, and maintains operations policies and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation.
- Identifies, recommends and implements changes to improve productivity. Directs the establishment, implementation and maintenance of production standards.
- B.S/B.A. in Biological Science, Engineering or related field with at least 15 years or operations and leadership experience
- 10+ years clinical and commercial cGMP operations experience, preferably with mammalian expression of recombinant proteins. Specific experience in manufacturing, supply chain or quality strongly preferred
- 10 years of progressively increasing leadership experience
- Experience overseeing and executing complex projects and programs
- Proven track record of success operating in a matrixed organization
- Experience interfacing with external clients preferred
Catalent's standard leadership competencies that are used to interview and for Performance & Development:
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops.