We have an immediate opening for a Director of Chemistry, Manufacturing and Controls (CMC) who will be responsible for the company’s activities for its ongoing early- and late-stage clinical trials. The successful candidate will be responsible for evaluation, selection and technical qualification of vendors, vendor management regarding production of clinical trial materials and future commercial products, overseeing studies required for high-quality regulatory submissions, and technical review of production documents. The position requires a high level of critical thinking and decision making.
● Manage the supply of clinical and future commercial products in compliance with current Good Manufacturing Practices
● Facilitate uninterrupted supply of clinical trial materials for all ongoing studies
● Communicate effectively to stakeholders. Represent the CMC Team when communicating externally.
● Create and maintain detailed CMC project plans to ensure clarity of deliverables and timing.
● Provide support to Management in assessing resource needs to achieve timelines and quality milestones.
● Develop tools and mechanisms for monitoring progress and problem solving with CMC project and functional area managers
● Manage day-to-day activities of external contractors carrying out cGMP activities.
● Provide technical and management input into evaluation, selection and qualification of contract manufacturers and associated vendors
● Work with Quality Assurance to develop and use appropriate SOPs for vendor oversight, including external change control, deviations, investigations, and data review
● Provide technical support for Batch Record approval, review, and final release of product
● Ensure timely supply of API and Raw Material in support of Drug Product production
● Prepare and review applicable CMC sections for regulatory submissions.
● 10+ years of experience in a pharmaceutical or biotechnology environment managing projects in CMC areas.
● Minimum BS, MS, or equivalent in biology, chemistry, bioengineering, or related field
● Experience with managing contract manufacturers and associated vendors
● Strong working knowledge of cGMPs and other requirements for pharmaceutical production
● Demonstrated understanding of the combination medical device / drug product development process from research through a commercial product including an understanding of the interdependencies of functional groups.
● Proficient in relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to general knowledge with shared work environments.
● Experience in GMP production, process development, scale-up engineering, analytical method development, formulation, and characterization.
● Exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.