Plant Operations Program Director
Job Type:
Regular Full-Time
Location:
Offsite, WA
Job Description:
Dendreon is seeking a seasoned Operations leader to provide leadership for the build and start-up of several new commercial manufacturing facilities. In order to support national facilities expansion plans, this position can be based in any U.S. location. This position will be accountable for the cross-site coordination of manufacturing facilities to ensure consistency and timeline compliance for production process and operational start-up. The Plant Operation Program Director will be the point of integration for the individual facility operational plans, and should have strong communication skills to successfully work the General Managers and Director of Operations at each individual site. This is a matrix management position for someone who enjoys building things and appreciates the power of team accomplishments.
General Summary:
Works with the General Managers and their operational leadership staff at each manufacturing site to ensure consistency in process establishment (e.g. transfer of global SOPs, completion of all local SOPs, technical transfer, process validation).
Integrates the project plans of each facility for operational start-up, electronic system deployment, regulatory documentation, and integration into the corporate supply chain to ensure timelines are met and budgetary goals aligned with corporate expectations.
Represents the operational leadership for the commercial manufacturing sites on the program team. Provides open and timely communication of progress, issues, risks and progress status to the team and program management.
Works with program management to ensure that all aspects of operational start-up are represented accurately in the project and program plans.
Escalates issues that will impede the successful completion of the program goals to program management and corporate senior leadership.
Ensures that all third-party vendors involved with the operational startup of the facilities are integrated properly into the program.
Job Requirements:
Bachelor’s degree or equivalent.
Typically 10 years related experience in commercial cGMP/FDA regulated industry.
Typically 10 years experience managing functions directly involved with GMP operations.
Strong knowledge of cGMP regulations.
Experience in developing and making formal presentations to executive management.
Experience with program and project management.
Experience in building GMP facilities and participating in the commissioning, validation and start-up of those facilities.
Working Conditions and Physical Requirements:
Ability to gown aseptically for work in Clean Room environments.
Travel 40-50% of the time will be required.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.