Senior Director / Head of CMC

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Job description

Job Description

We are seeking a highly motivated leader to join us as Senior Director /Head of CMC. This role will be responsible for leading all CMC-related activities from process development through commercialization. The ideal candidate will be an experienced pharma/biotech professional with an outstanding record of accomplishment in commercial manufacturing of small molecule drugs and drug candidates, process development, quality, and supply chain aspects. The candidate will also have experience in the submission and maintenance of CMC sections of regulatory submissions and all stages of commercialization.

Essential Duties and Responsibilities

• Oversee and provide technical leadership, strategic direction, risk assessment and oversight for translation of the corporate strategy into supportive strategies for pharmaceutical manufacturing, quality control, process development, analytical development, technology transfer and validation.
• Technical oversight and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (DS) and Drug Product (DP) in support of our clinical programs through commercialization.
• Ensure robust, scalable, efficient, cost-effective manufacturing of drug substances and drug products through commercialization.
• Prepare contingency plans as appropriate and communicate issues, risks, and proposed mitigation plans; execute agreed upon plans in a timely manner.
• Author, review and/or approve CMC documents related to INDs, CTAs, NDAs, MAAs and/or other required regulatory submissions.
• Serve as primary CMC representative at key meetings with regulatory agencies.
• Effectively work within the CMC development department and with cross-functional team leaders to achieve corporate and program goals
• Other duties as assigned.

Job Requirements

• Ph.D. in chemistry, organic chemistry, chemical engineering, or a related scientific discipline.
• Minimum of 15 years' experience. Experience must include small molecules in a pharmaceutical or biotechnology environment while overseeing CMC responsibilities in all stages from pre-clinical to commercialization.
• Strong background in outsourced drug substance, drug product, and clinical development through commercialization is required.
• Experience in outsourced development through commercialization of solid oral dosage forms and modified release formulations; experience in long-acting depot formulations, inhaler, and transdermal delivery a plus.
• Substantial experience in managing global CRO/CMOs for the manufacture of cGMP drug substances, and drug products.
• Knowledge of GMP quality systems.
• Must possess a strong project leadership presence with excellent organizational skills and strong attention to details, excellent written and verbal communication skills.
• Must possess strong technical judgment; a problem solver with the ability to successfully and proactively identify and manage potential risks across all relevant areas, to effectively inform key updates and issues to the executive leadership.
• The ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion.
• Successful track record of developing collaborative, productive relationships across all functions and levels both internally and externally and the ability to manage and gain support of multiple stakeholders.
• Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
• Ability to effectively present information to top management, and/or boards of directors
• Ability to think strategically and translate into action
• Available to travel if/when needed.