Vice President, Technical Operations

The Vice President, Technical Operations will be responsible for the st rategic vision, leadership, and operational guidance of the Company’s pharmaceutical process development, clinical manufacturing, and controls.

R esponsibilities:

• Develops and executes rigorous strategies to support long-range strategic and operating plans for Technical Operations as it relates to regulated programs.

  Sets near-term priorities for the teams executing in these areas

• Leads the strategic planning process with respect to timing and implementation of CMC; identifies potential risks and pursues mitigation
• Directs the design and development for the manufacturing processes and control strategy.

  Drives continuous improvement in the drug development process through technological innovation and alignment with regulatory and commercial manufacturing requirements

• Establishes the IND-supportive strategy and optimal implementation plan to support advancement of drug development pipeline
• Provides timely reports regarding the status, progress, potential risks/mitigation strategies and future needs for all Technical Operations
• Presents strategic plans, progress, risks, and mitigation strategies in discussions and meetings with the Board of Directors
• Provides oversight of supply chain management activities
• Plans and confirms appropriate studies to support each clinical program; contributes pharmacometric support for clinical programs in some situations as required
• Solicits scientific, regulatory, and other expert input, both internally and through outside experts, as needed to guide the process and ensure the most expeditious and efficient route while not compromising quality or safety
• Develops and maintains external relationships with thought leaders, regulatory officials, outside collaborators and corporate partners, and key vendors
• Complies with applicable policies regarding health, safety, and environmental policies

J ob Requirements:

• PhD in Chemistry or related area and at least 15 years of relevant experience within the biopharmaceutical industry, of which 10 years should be in a management or leadership role leading the CMC organization; or equivalent
• Proven track record of effectively leading CMC, and related activities for early through late-stage product development, including preparation for successful market approval and commercialization
• Demonstrated technical/scientific expertise of biopharmaceutical processes, at both process development and manufacturing scales of operation; knowledge with a variety of analytical methods and techniques
• Must have experience managing CMOs in CMC, and outside expert consultants in a variety of disciplines, including demonstrated ability to oversee multi-disciplinary work outside specific personal expertise
• Expertise in developing regulatory strategy as it applies to manufacturing operations and registration strategy, including experience in successful regulatory interactions , and demonstrated knowledge of relevant regulatory requirements
• Strong leadership and management skills; ability to balance the needs of the organization with the tactical day
  – to-day activities.

  Able to successfully motivate team members to be innovative and collaborative while driving results

• Must be results-oriented, hands-on and creative problem solver with a demonstrated ability to apply innovative thinking to problem solving for novel challenges
• Excellent communication, including: writing, presentation and interpersonal skills
• Ability to travel as needed up to 30% [domestic and international]