Beta Cat Pharmaceuticals is a clinical stage pharmaceutical company developing a novel injectible compound for treatment of a broad range of cancers and fibrotic disease. The Director, CMC will oversee and direct all chemistry, manufacturing and controls (CMC) regulatory and manufacturing strategies and implementation for Beta Cat products. This individual will provide leadership and management in all aspects of planning and execution of product development and manufacturing activities. Responsibilities will include oversight of active pharmaceutical ingredient (API) and drug product (DP) production, process and product development and validation for manufacturing scale up and preparation of manufacturing and development sections of CMC regulatory submissions, S/he will work closely with the product development team and our network of consultants and contract manufacturers ensuring alignment between strategy and operational activities. This individual will also be responsible for leading the CMC regulatory activities, strategies and submissions supporting the development and commercialization of Beta Cat’s novel compounds.
- Actively participates in the developing the overall CMC strategy; plan and directs all activities related to ongoing API and DP process development and validation.
- Responsible for timely delivery of drug product for clinical trials, working in collaboration with product development and clinical teams. Oversees the activities of contract manufacturers. Provides technical review and approval of master and executed batch records for API and DP. Works closely with QA and QC to ensure batch release.
- Identifies key risks, timeline and resource issues, and develops mitigation plans.
- Creates budgets and forecasts CMC related expenses, including contract organizations and consultants. Serves as the primary point of contact for all manufacturing related vendor relationships.
- Ensures compliance with all relevant quality and safety guidelines, and the Company’s quality assurance program.
- Ensures that appropriate CMC documentation is developed and executed. Reviews ancillary CMC documents and reports for completeness and accuracy and for compliance with regulations.
- Compiles, reviews and approves CMC modules for development and marketing registration applications, amendments, and supplements for submission. Attends and participates in meetings with the FDA or other regulatory bodies.
- Stays attuned to all significant developments in the fields affecting the Company’s products.
- Advanced degree in Chemistry, Chemical Engineering or related field and at least 8 years of experience in API and drug development within the pharmaceutical industry; or equivalent. Must have at least 3 years of management experience.
- Must have previous experience in API and drug product development and manufacturing of a small molecule injectable drug from early through late stage clinical development
- Must have industry experience with expertise in manufacturing operations and strategic planning;
- Proven track record of developing and managing timelines and budgets, with experience managing a team of consultants, vendors and contractors.
- Proven experience preparing process development and manufacturing sections of various regulatory documents. Direct experience interacting with FDA is preferred.
- Stays current on industry trends, practices and regulatory guidelines
- Excellent interpersonal and management skills with the ability to maintain positive relationships with management, colleagues, staff, and external contract organizations
- Effective and clear communicator, verbally and in writing
- Displays strong analytical and problem-solving skills
- Competitive base salary
- Comprehensive & cost-effective benefits
- Annual cash incentive
- Stock Options
For more information please send your resume to HR@betacatpharma.com