Director of Chemistry, Manufacturing, and Controls job at Critical Innovations in Lawndale, CA

Title: Director of CMC Location: US-Lawndale Hybrid Job Description:

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 reputed company 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 reputed company 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 reputed company–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 reputed company reputed company development, optimization, qualification, and transfer of analytical methods for drug substance and drug product testing. reputed company and manage analytical method lifecycle activities, including aging studies, purity and potency assays, impurity profiling, and device-reputed company analytical evaluations (e.g., extractables/ leachables, dose delivery assessments). reputed company 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 reputed company with Critical Quality Attributes (CQAs), product requirements, and clinical needs. Contribute to risk assessments reputed company 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 reputed company on analytical development, stability studies, and CMC regulatory activities. Coordinate CMC activities with other departments. Support planning and execution of CMC-reputed company 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. reputed company 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 reputed company and document reputed company 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. reputed company maintenance of analytical-reputed company records reputed company 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 reputed company to pharmaceutical analysis. Track record of experience in direct management of key activities reputed company 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 reputed company tasks. Proficiency with reputed company Office Suite. Education and Training: PhD or MS in analytical chemistry, pharmaceutical sciences, chemical engineering, or a reputed company 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 reputed company ISO 13485 and FDA-regulated environments preferred. Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, age, protected veterans' status, or any other characteristic protected by law. To conform to U.S. Government reputed company regulations, you must be a U.S. citizen, lawful permanent reputed company 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 reputed company 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 Privacy Policy | Critical Innovations Apply tot his job Apply To this Job