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Head of Chemistry, Manufacturing, and Controls
2 months ago
We are seeking a highly experienced and skilled Director, CMC Development to join our team at Evergreen Theragnostics, Inc. This is a key leadership position that will oversee all aspects of Chemistry, Manufacturing, and Controls (CMC) product development, scale-up, and validation.
Key Responsibilities- Lead CMC Product Development: Oversee the development of radiopharmaceutical products, ensuring compliance with regulatory requirements and industry standards.
- Validate Chemistry Formulations: Validate chemistry formulations for new products, ensuring their safety, efficacy, and quality.
- Collaborate with Cross-Functional Teams: Lead cross-functional project teams, including production, quality, and regulatory, to validate product formulations, analytical methods, and regulatory filings.
- Manage External Vendors: Manage external vendors, including CDMOs and quality control laboratories, to ensure timely and cost-effective delivery of products and services.
- Develop Improvement Roadmaps: Define and implement roadmaps for improvement projects to enhance process quality, reliability, and scale.
- Ensure Effective Project Management: Manage projects, including maintaining schedules, milestones, and tracking open issues, to ensure timely completion and quality delivery.
- Responsible for Product Remediation: Resolve all aspects of product remediation activity related to regulatory submissions.
- Develop and Review Technical Documents: Draft and review product development plans, project design reviews, technical documents, and reports.
- Oversee Test Method Development: Oversee the development of clinically relevant methods that adequately challenge product design and processes.
- Measure and Improve Internal Processes: Responsible for the measurement and effectiveness of internal processes.
- Education: PharmD, PhD, or equivalent advanced scientific degree.
- Experience: 5-10 years of CMC experience in the pharmaceutical industry.
- Knowledge and Skills: Knowledge of radiopharmaceuticals, the drug approval process, and experience overseeing or working on teams tasked with gaining FDA approval of branded and generic products.
- Personal Qualities: Excellent people skills, ability to partner with executive leadership, navigate interpersonal communication, and compose clear and professional written business correspondence.
- Flexibility and Adaptability: Flexible and able to multitask and work in a complex and fast-moving environment, while driving toward solutions.
