Senior Vice President, CMC

Position Summary

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.

The SVP, CMC is responsible for translating the corporate strategy into supportive strategies for global pharmaceutical manufacturing, fill/finish, packaging, supply chain, logistics and quality control (including process development, analytical development, technology transfer, validation, etc.) from early-mid stage product development through global manufacturing for commercial products. S/he oversees and provides technical leadership, strategic direction, risk assessment, and oversight for successful long-range planning and execution across all supporting functions.

S/he leads assessments and analyses resulting in recommendations for contract manufacturing organization (CMO) qualification and negotiations that are consistent with, and supportive of, the global strategic plan and translation of strategy into an executable series of pharmaceutical manufacturing plans and quality control systems to ensure deliverables meet approved budgets, timelines and adhere to all international and national laws, guidelines and required quality control standards. The position has ultimate responsibility for the company’s strategy and oversight of supply chain/manufacturing and management of all technical operations activities to deliver products to clinical trials and/or market within defined regulatory, legal, quality and cost standards.

The ideal candidate will be a seasoned pharma/biotech executive with an outstanding record of accomplishment in R&D manufacturing of biologics, quality, supply chain management and logistics and with experience in the global submission and maintenance of CMC sections of regulatory (BLA) filings. Candidates will have previously worked on biologics CMC development programs that have been filed and approved for registration with the FDA and other global regulatory bodies.

This is an outstanding opportunity to serve as a driving force in building and expanding First Tracks Bio’s pharmaceutical development and manufacturing organizations, and one that will provide broad business leadership challenge, accountability and impact for the successful candidate.

Essential Functions

• 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.

Other Information

• Position may require occasional evening and/or weekend commitment.
• Position may require domestic and international travel.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

May be required to travel by plane or car

This position requires working with biological and/or chemical hazards.

_All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status._