Director, CMC Development
2 weeks ago
Director, CMC Development
About Us
Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting edge cancer research laboratories. The company expects rapid growth in the next few years.
Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.
We are now seeking a Director CMC Development to oversee all CMC aspects of product development, scale-up, and validation.
Responsibilities:
- Leads all aspects of CMC product development for radiopharmaceuticals.
- Validates chemistry formulations for new products.
- Leads cross-functional project teams including production, quality, and regulatory in order to validate product formulations, analytical methods, and all aspects required for successful regulatory filings.
- Manages external vendors throughout the product development process including CDMO’s and external quality control laboratories.
- Defines roadmap of improvement projects to enhance process quality, reliability, and scale.
- Ensures effective project management including maintaining project schedules and milestones, and tracking open issues.
- Resolves all aspects of product remediation activity related to regulatory submissions.
- Drafts and reviews product development plans, project design reviews, technical documents, and reports.
- Reviews and approves execution of verification and validation protocols and reports.
- Oversees the test method development of clinically relevant methods that adequately challenge product design and processes.
- Responsible for the measurement and effectiveness of internal processes.
Education and Qualifications:
- PharmD, PhD or equivalent advanced scientific degree.
- 5-10 years CMC experience in pharmaceutical industry.
- Knowledge of radiopharmaceuticals a plus.
- Knowledge of the drug approval process, and experience overseeing or working on the team tasked with gaining FDA approval of both branded and generic products.
- Excellent people skills, with the ability to partner with an Executive Leadership team.
- Able to navigate interpersonal communication and compose clear and professional written business correspondence.
- Possess personal qualities of integrity, credibility, and commitment to the organization’s mission, vision, and values.
- Flexible and able to multitask and work in a complex and fast-moving environment, while also driving toward solutions.
- Demonstrated resourcefulness in setting priorities and guiding investment in people and systems.
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