Project Manager

Description:

The successful candidate will effectively manage and coordinate Biological Manufacturing technical projects and initiatives within Zoetis biologics manufacturing facilities. The scope of the support will include technical investigations, Cost Improvement Projects (CIPs), VMRD product transfers/launches, as well as internal GMS transfers across the network. This role will also provide leadership for the Process Scientists who have responsibility for supporting the Manufacturing organization with technical investigations.

The position requires strong leadership (with and without authority) and demonstrated communication skills in order to collaborate across organizational lines (Opex, Quality, Regulatory, EHS, Validation, Supply Chain, and Operations) to ensure timely resolution of major investigations and process flow improvements. The ideal candidate would have a strong people leadership experience and a solid technical foundation in in analytical methods, process development, commercialization, and process capability. The candidate will be required to understand key technical data from the GMT bench scientists in order to represent the site on VMRD-led Co-development teams, raw material assessments, and technical transfers. The candidate will work with US, International and EU Regulatory, sites, and center groups to develop and execute strategies for filing, defending, and launching new products.

Responsibilities

The successful candidate will be expected to deliver allocated projects on budget and time in order to meet business objectives. The candidate will be expected to make decisions that impact their own work and exercise judgment to complete assigned tasks. The candidate will lead complex scientific teams to support site investigations, bad actors, and CIP initiatives as their primary role. The candidate will be expected to manage the following team dynamics: 1. Accountability, 2. Leadership with influence (with and without authority), 3. Consensus building, 4. Definition of team roles and responsibilities, 5. Facilitate recommendations of technical team to management, and 5. Deliver projects on time and budget.

• B.S. or B.A. degree with 9-13 years experience in biological or related science with emphasis in microbiology, virology, bacteriology, or immunology. Minimum of 2 years of people leadership experience. Minimum of 10 years’ experience in Biologics industry with at least 1-2 years of experience in Biological Development. Five or more years of experience in general and technical management of projects with demonstrated ability to resolve technical issues, addresses validation requirements, prepares and administers budgets. Demonstrated expertise in areas of Biological sciences including production, Quality control, Compliance, Regulatory Affairs and Biological Research and development will be considered strongly. Additional key attributes desired are demonstrated ability to function and influence in a team/matrix environment, good interpersonal skills, communication skills, computer skills and working knowledge of key regulatory authorities (USDA, EMA and VMD). Demonstrated expertise in Project management/Coordination. Prior experience in managing capital projects is a plus.
• Laboratory and/or manufacturing experience in biological manufacturing and/or testing is desirable, as well as knowledge of biological product formulation, emulsions, lyophilization, viral/bacterial antigen production systems and/or testing for veterinary biologics manufacturing. A working knowledge of vaccine production methods and experimental design and experience in cGLP or cGMP is also desirable.
• High degree of personal motivation and attention to detail.
• Strong oral and written communication, excellent interpersonal skills.
• Strong commitment to safety, product quality, and working knowledge of RFT (Right First Time) principles. Continuous improvement mindset using lean six sigma principles.
• Working knowledge in process capability assessment and continuous process verification is preferred.
• Strong oral and written communication, excellent interpersonal skills, and ability to interact across divisional boundaries.
• Strong commitment to product quality, continuous improvement and working knowledge of RFT (Right First Time) and Lean principles.
• Typical office based working conditions of sitting at the computer and teleconferencing.
• Some travel may be required as part of project transfers.
• Occasional weekend work may be required.
• Must be able to walk or stand for long periods of time.
• Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip.
• Frequent lifting and carrying of 5 to 25 lbs