Senior/Executive Director, Head of Technical Operations

About the position

The Senior/Executive Director, Technical Operations will be responsible for all Chemistry, Manufacturing, and Controls (CMC) technical functions, including Drug Substance, Drug Product, Analytical, and Clinical Supply Chain. In addition, this position will require oversight of all CMC regulatory submissions to various health agencies and cross-functional collaboration with quality assurance, research, toxicology, and other relevant functions. This person will report to the Vice President, Chemistry.

Responsibilities

• Establish, lead, and manage the internal Technical Operations function, including mentorship of all Technical Operations staff, and work with Human Resources to build recruiting roadmap to ensure that Technical Operations staffing allows our capabilities to scale with manufacturing needs
• Provide strategic oversight to ensure uninterrupted API supply for toxicology and clinical
• Collaborate within project teams and across other functional groups including medicinal chemistry, pharmacology, toxicology and clinical to ensure programs stay on time and corporate goals are met
• Oversee the strategy, design and execution of all manufacturing campaigns
• Identify CMC-related risks and facilitate mitigation planning
• Oversee the authoring of CMC sections of regulatory submissions (e.g., INDs, CTAs, NDAs) and responses to queries from health agencies
• Work with QA to ensure compliance in all activities
• Establish in-house capabilities to address technical issues arising during the development process
• Build and maintain strong relationships with CDMOs, consultants and other external partners to enhance Technical Operations resources and capabilities.
• Work closely with Finance to develop budget forecasts for all CMC operations, including scenario planning for possible risks

Requirements

• PhD in Chemistry, Chemical Engineering, or other related field, and 10+ years of experience in the pharmaceutical industry, or Master's degree and 12+ years of experience, or Bachelor's degree and 15+ years of experience, with professional experience directly related to above-mentioned Technical Operations activities, with sufficient exposure to each of DS and DP manufacturing and troubleshooting, and clinical supply chain.
• Experience in fast-moving early-stage biotech is preferred
• Deep expertise working, collaborating with, and managing CDMOs
• Excellent synthetic chemistry knowledge with a focus on optimizing small molecule synthesis routes for scalability
• Good knowledge and understanding of cGMP of small molecule DS/DP and of the US, Canadian and EU regulatory environments; previous experience with IND and CTA CMC submissions preferred
• Good knowledge of formulation options and troubleshooting
• Excellent written and oral communication skills, including experience in technical writing in support of regulatory submissions such as INDs
• Excellent attention to detail and commitment to providing accurate, high-quality work
• Excellent organizational skills and the ability to manage multiple competing priorities
• Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team
• Strong leadership skills with experience managing and mentoring scientific teams

Nice-to-haves

• Experience in fast-moving early-stage biotech

Benefits

• Equal Opportunity employer