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.

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.

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

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

Physical Demands

• Sit and talk or hear.
• Frequently use hands to finger, handle, or feel.
• Occasionally lift and/or move up to 10 pounds.

Position may require occasional evening and/or weekend commitment.

Position may require domestic and international travel.

Salary Description

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

Life at AnaptysBio

AnaptysBio is a clinical-stage antibody development company advancing therapeutic antibody product candidates focused on unmet medical needs in inflammation. We develop our product candidates to address emerging biological targets using our proprietary antibody discovery technology platform, which is based upon a breakthrough understanding of the natural process of antibody generation, known as somatic hypermutation, or SHM, and replicates this natural process of antibody generation in vitro. Our strategy is to advance the development and commercialization of our proprietary product candidates, and for certain programs, establish partnerships with leading biopharmaceutical companies where we retain certain development and commercialization rights in the United States. Our wholly-owned product pipeline includes etokimab (ANB020) and ANB019, which are being developed to treat severe inflammatory disorders with unmet medical need. We are advancing etokimab, an antibody that inhibits the activity of interleukin-33, for the treatment of moderate-to-severe adult atopic dermatitis, severe adult eosinophilic asthma, and adult chronic rhinosinusitis with nasal polyps (CRSwNP). In addition, we are developing our ANB019 product candidate, an antibody that inhibits the interleukin-36 receptor, for the treatment of rare inflammatory diseases called generalized pustular psoriasis (GPP) and palmoplantar pustulosis (PPP). Our company is led by a strong management team with a proven track record of successfully growing biotechnology companies with deep experience in antibody discovery and development, collaborations, operations and corporate finance. Additionally, multiple AnaptysBio-generated antibodies have entered the clinic under our immuno-oncology-focused collaboration with TESARO and inflammation-focused collaboration with Celgene. For more information, visit www.anaptysbio.com.

Thriving Here & What We Value

• Embracing accountability, transparency, and humility
• A meaningful work environment with respect for all roles
• Diversity as a foundation for success
• Collaboration in cross-functional teams
• Making a difference for those with autoimmune/inflammatory diseases