Director, Manufacturing

Director, Manufacturing

Job Type: Regular Full-Time Location: Morris Plains, NJ

Job Description: Dendreon is seeking a highly motivated Director of Manufacturing to establish and maintain control, accountability and ownership of the manufacturing operations; communicate manufacturing management goals and visibility for all levels of the staff; and focus on regulatory compliance and leadership for manufacturing operations in support of the clinical and commercial manufacturing at the New Jersey Immunotherapy Manufacturing Facility. This is a great opportunity to become part of a company that is being recognized as an industry pioneer in the manufacture of personalized medicines. General Summary: * Manages cGMP manufacture and release of drug product to meet all clinical trial and commercial needs as appropriate. * Executes Operations group production plan; supports the planning of production schedules and coordination of material requirements, as well as formulating and recommending manufacturing policies and programs. * Works closely with QA function to assure CMC quality systems meeting regulatory compliance requirement. * Creates, tracks and manages project budgets, timelines, tasks, responsibilities and activities to meet Dendreons customer expectations. * Identifies and tracks metrics for monitoring manufacturing and process performance and/or consistency. * Mentors and develops personnel, including supervisory / management staff. * Collaborates with other departments during planning and process improvement activities to ensure timely completion of all operational areas objectives and milestones. * Communicates drug manufacturing issues and information to committees, teams and interested groups within the company. * Contributes to department strategic management. Requirements: * Bachelors degree in a scientific discipline or equivalent. * Typically 10 years related experience in manufacturing of commercial pharmaceutical or biotechnology derived parental and/or cellular therapies preferred. * Typically 5 years experience managing supervisory personnel and contributing toward the development of department strategy. * Knowledge of cGMP/ICH/FDA regulations. * Experience in developing and making formal presentations to executive management. * Experience with department budget planning, management and reconciliation. * Proficient in MS Office applications. * Demonstrated ability to successfully interact with the FDA. * Previous successful Pre-Approval Inspection experience is desirable. * Experience with ERP and/or MRP systems is a plus. Working Conditions and Physical Requirements: * Ability to gown aseptically for work in Clean Room environments. * Handling of biologic materials. * Some travel may 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.

Please refer to job code dendreon-10599 when responding to this ad.

Category:	Manufacturing
	> Other Manufacturing
Location:	Morris Plains, NJ
County:	Morris County
ZIP Code:	07950
Pay Rate:	Open
Job Terms:	full time
Company:	Dendreon Corporation
Phone:	email only please
Fax:	email only please