The Director CMC will facilitate product development by leading the planning and execution of the CMC strategy for one or more pipeline products. The Director, CMC, will be responsible for developing and implementing CMC strategies and tactics relating to drug substance manufacturing, formulation and analytical development, drug product manufacturing and supply chain operations across multiple geographic regions. The individual acts as an advisor/liaison to senior management in order to plan, evaluate and recommend CMC strategy. The successful candidate will be responsible for ensuring successful outcomes of CMC activities in support of the product strategy by partnering with CDMOs and internal functional teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Develop and execute CMC activities for one or more projects, including development of goals and associated timelines, budget, and risk assessment/mitigation tactics
• Lead projects from a technical perspective including drug substance manufacturing, formulation and analytical development, drug product manufacturing and supply chain operations.
• Manage complex sets of project activities by utilizing simple tools, exhibiting good judgement and reacting deftly to changes in project scope, timelines or priority
• Proactively identify issues with respect to CMC projects, develop solutions and drive to resolution
• Coordinate decisions with, and provide CMC expertise to, the Quality and Regulatory Affairs functions
• Bridge development projects from the Research organization into the CMC arena and through all subsequent stages of development
• Act as the lead and the key point of contact for CDMOs, and make astute and well-thought-out decisions based on an assessment of operational and strategic considerations
• Support development and implementation processes for efficient supply of Rigel’s product(s) to all non-clinical, clinical, and commercial sites.
KNOWLEDGE AND SKILL REQUIREMENTS:
• Minimum of a BS degree in Chemistry, Biochemistry, or related pharmaceutical science required; an advanced degree is desirable
• Minimum of 10 years of industry experience in pharmaceutical product development, with a minimum of 5 years in Chemistry, Manufacturing and Control (CMC) environment;
• Experience with multiple dosage forms a plus
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timeline
• Work well with employees across the entire organization and have the ability to work independently and as part of a team.
• Ability to prioritize and handle multiple projects simultaneously.
• Strong business acumen and ability to make sound decisions that contribute positively to the business.
• Strong negotiating skills and ability to think creatively and develop creative solutions.
• Demonstrated leadership excellence and skills in delegating, influencing and in managing budgets, resources, and priorities.
• Flexible and adaptable style, with a willingness to take on new challenges and resilience to respond to emerging challenges
• Excellent communication and interpersonal skills
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.