Research Triangle Park, NC
The Director, Manufacturing, will provide leadership of the Biogen Idec RTP Manufacturing Department. This person will be responsible for directing manufacturing management (including Associate Directors, Managers and Administrative staff) for both Large-Scale and 2K-Scale production. The Director establishes and maintains budgetary responsibility, control and accountability and ownership of the manufacturing deliverables against plan. This person develops, communicates and leads the implementation of manufacturing-related strategic objectives. The Director must be highly visible and inspirational for all levels of the staff, with a focus on compliance and continuous improvement.
Plans, directs and coordinates all areas of manufacturing to assure that production schedules, manufacturing compliance, regulatory and budget requirements are met.
Develops production schedules and resource plans to achieve corporate planning deliverables.
Develops and maintains budget (expense and capital) for manufacturing.
Ensures implementation and adherence to safety programs.
Establishes metrics for the manufacturing group, tracks progress and is accountable for achieving metric targets.
Develops strategic objectives for the group and leads progress towards achieving the objectives.
Supports regulatory submissions, participates on CMC teams and represents manufacturing in regulatory inspections.
Participates on technology transfer and start-up teams.
Master’s Degree (MS) from a university with an emphasis in Science/Engineering; or a minimum of 12 years related experience and/or training; or an equivalent combination of education and experience.
A minimum of 4 years working directly in biotech or biological manufacturing.
Must have at least 6 years of experience managing groups of 6 or more.
In-depth knowledge of cGMP’s, industry best practices (including Operations Excellence principles), bioprocessing technologies and business processes associated with biotechnology operations.
Experience with multiple regulatory inspection agencies, such as EMEA and FDA.
Extensive experience in leading organizations in a biotechnology (or closely related) manufacturing environment.
Demonstrated ability to dramatically improve/turn-around operations' performance.
Demonstrated ability to enhance a culture of collaboration and innovation -- a proven team player.
Excellent verbal and written communication skills, as well as strong presentation skills.
Proven leadership skills, including demonstrated ability to develop and implement strategic and tactical objectives.
Exceptional people management skills, with a record of developing and inspiring staff.
Experience in new product start-up, technology transfer and multi-product manufacturing.
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