Director of CMC

Overview

The Director of CMC is responsible for day-to-day leadership and execution of Critical Innovations’ Chemistry, Manufacturing, and Controls (CMC) activities, with primary oversight over analytical development, CMC strategy, and CMC program management. This position plays a key role in ensuring that the Company’s drug-led products meet internal scientific standards and applicable regulatory requirements. The Director of CMC leads the development, optimization, qualification, and transfer of analytical methods;

oversees CMC documentation and regulatory-support activities; and provides cross-functional coordination to ensure alignment between other departmental partners. This position does not oversee formulation or process development but collaborates closely with those teams to ensure analytical readiness, CMC coherence, and timely development support. The ideal candidate possesses strong analytical chemistry/scientific expertise, excellent technical writing capabilities, a proven track record in CMC or analytical development for pharmaceuticals and/or combination products, and a deep familiarity with CMC regulatory expectations (e.g., 21 CFR Parts 210/211, 21 CFR Part 4, ICH Q8–Q11).

The Director of CMC must be able to work independently, manage multiple projects, and operate effectively in a lean organization with extensive interaction with external contract research organizations (CROs) and cross-functional internal teams. This is an on-site, full-time position.

VP of Research

• Analytical Development Oversight — Oversee development, optimization, qualification, and transfer of analytical methods for drug substance and drug product testing.
• Develop and manage analytical method lifecycle activities, including aging studies, purity and potency assays, impurity profiling, and device-related analytical evaluations (e.g., extractables/leachables, dose delivery assessments).
• Oversee outsourced analytical work, including method development, sample coordination, submission, review, and interpretation of test reports.
• Ensure analytical documentation meets internal and regulatory standards, including method development reports, validation protocols, and method transfer packages.

• Support the Vice President of Research in establishing the Company’s end-to-end CMC development and regulatory strategy.
• Define analytical acceptance criteria and control strategies aligned with Critical Quality Attributes (CQAs), product requirements, and clinical needs.
• Contribute to risk assessments related to analytical methods, stability, and drug–device compatibility.
• Ensure that analytical development aligns with combination-product requirements, including interactions between drug and device materials.

• Manage CMC timelines, milestones, deliverables, and cross-functional coordination.
• Track and communicate progress on analytical development, stability studies, and CMC regulatory activities.
• Coordinate CMC activities with other departments.
• Support planning and execution of CMC-related activities at CROs and Contract Development and Manufacturing Organizations (CDMOs).

• Draft, review, and contribute to CMC sections of regulatory submissions (e.g., IND Module
  3), method descriptions, stability summaries, analytical justification narratives, and combination-product integration sections.
• Contribute to development of CMC regulatory strategy.
• Provide analytical and CMC subject-matter expertise during regulatory interactions.
• Oversee the maintenance of accurate documentation for analytical methods, test results, and CMC records in compliance with quality system requirements.

• Collaborate with engineering and quality/regulatory to ensure analytical and CMC readiness for combination-product development.
• Support process and formulation development teams by providing analytical insight, specifications, and method support needed for process work.
• Participate in Management Review activities as requested.

• Perform and document all work in accordance with ISO 13485:2016, FDA’s Quality Management System…