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 position is designated as a full-time on-site role and is expected to be performed primarily at the Company’s assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law.

Reports to:

VP of Research

Duties and Responsibilities:

The responsibilities of the Director of CMC typically include:

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.

CMC Strategy

• 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.

CMC Program Management

• 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).

Regulatory Support

• 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.

Cross-Functional Collaboration

• 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.

Compliance and Documentation

• Perform and document all work in accordance with ISO 13485:2016, FDA’s Quality Management System Regulation (21 CFR Part 820), cGMP (21 CFR Parts 210 and 211), combination-product requirements (21 CFR Part 4), GLP, and internal Quality procedures.
• Oversee maintenance of analytical-related records within product history files and Design History File components relevant to the drug constituent part.

Skills and Experience:

• Excellent written and oral communication skills.
• Strong analytical and problem-solving abilities related to pharmaceutical analysis.
• Track record of experience in direct management of key activities related to CMC development and strategy.
• Experience with CMC activities for combination products preferred.
• Extensive experience in analytical method development, optimization, and troubleshooting to support small- and large-molecule characterization.
• Proven track record in analytical method development, optimization, and troubleshooting.
• Experience leading a team of other scientists.
• Demonstrated leadership for outsourced analytical work at CROs/CDMOs.
• Proficiency in generating and reviewing CMC documentation for regulatory submissions.
• Ability to work cross-functionally with scientific, engineering, and regulatory personnel.
• Strong organization and time-management skills, with the ability to manage multiple concurrent tasks.
• Proficiency with Microsoft Office Suite.

Education and Training:

• PhD or MS in analytical chemistry, pharmaceutical sciences, chemical engineering, or a related scientific discipline.
• 7+ years of experience in CMC or analytical development for pharmaceuticals and/or combination products preferred.
• Experience supporting IND or equivalent regulatory submissions preferred.
• Experience working within ISO 13485 and FDA-regulated environments preferred.

Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law.

To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

Benefits:

• 401(k) Safe Harbor Plan
• Healthcare Insurance: Medical, Dental and Vision
• Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance
• Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave
• Tuition Reimbursement Program
• Performance Bonus
• Incentive Unit Plan
• Flexible Schedule
• Lunches, Snacks, Events

Schedule:
Monday to Friday

Salary:
$140,000 -180,000 per year

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