Director of CMC

About the role

The Director of CMC is responsible for overseeing Critical Innovations’ Chemistry, Manufacturing, and Controls (CMC) activities, with primary oversight over analytical development, CMC strategy, and program management. This role ensures that the Company's drug-led products meet internal scientific standards and regulatory requirements.

Duties and Responsibilities

• 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.
• Cook up CMC activities with other departments.
• Support planning and execution of CMC-related activities at CROs and 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.

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

Pay

$140,000 -180,000 per year