Senior Vice President, CMC

About the role

A key member of its leadership team is the role of Senior Vice President, Chemistry, Manufacturing and Controls (SVP, CMC) reporting to the CEO. This role is tasked with the mandate to provide the vision, leadership, strategy and management skills to oversee, lead and further expand the manufacturing of company’s proprietary programs through preclinical, clinical and commercial stages. In particular, the SVP of CMC will have oversight over the company’s entire out-sourced manufacturing effort, the company’s Programs progresses.

Responsibilities

• Leads, manages and coordinates the full breadth of all outsourced manufacturing operations activities and budget for the company’s portfolio in collaboration with the research, clinical development, and business teams.
• Play a key role in developing and implementing integrated CMC regulatory strategies for First Tracks Bio’s pipeline projects.
• Assures a reliable preclinical, clinical and future supply of safe, high-quality drug products and will lead the manufacturing strategies and address capacity issues.
• Directs and manages the company’s external contract research and manufacturing operations and ensure appropriate processes are in place to support clinical manufacturing.
• Provides a nexus for communication from the executive level to relevant technical leaders and between technical leaders and works closely with technical leaders to translate strategic plans and evolving company goals into actionable tactical plans, set priorities, measure results, assess and implement new learnings for continual improvement, and report progress to the executive staff and the CEO.
• Develops approaches acceptable to the CEO and Board to communicate risks, recommended mitigation strategies, and project status to stakeholders, including the Board, and to obtain buy-in for relevant recommendations from managers and directors.
• Oversees, manages, and provides development opportunities for and technical leaders in all areas of pharmaceutical development, manufacturing, planning, procurement, logistics, production control, and quality control functional managers, accountable for implementing the executive strategy by clearly defining deliverables in the context of the corporate plan for each functional area and then measuring the results against the goals. This includes listening to and gathering any concerns, finding common ground solutions, highlighting necessary changes, and then collaborating with the executive committee to endorse changes in the strategic plan, where necessary.

Requirements

Education & Experience:

• B.S is required, PhD preferred.
• Minimum of fifteen years’ experience in a senior management level role in CMC, with increasing responsibilities.
• A strong record of accomplishments and successful leadership experience in biologics drug development and commercial drug product manufacturing, preferably with experience in a biotechnology company that has scaled from early-stage product development to commercial or near commercial-stage.
• Proven track record of establishing a global commercial product supply chain and having had successful interactions with the regulatory agencies, as demonstrated by timely global CMC submissions, approvals and clinical and commercial supply of pharmaceutical compounds, specifically biologics drugs.

Qualifications

None specified in the job posting.

Skills

None specified in the job posting.

Benefits

None specified in the job posting.

Pay

$306k-$445k, 35% bonus, 10% 401k, Options & RSU

Schedule

Full time