Location: Remote or West Lafayette, IN
Company Overview: Eradivir is a clinical-stage biotechnology company dedicated to translating innovative therapies from academic and internal labs through human clinical trials. We are committed to advancing science and improving patient outcomes through cutting-edge research and development.
Position Summary: Eradivir is seeking a Director, CMC to manage oversight of the small molecule CMC program across all phases of Preclinical and Clinical Development. Primary responsibilities will include working closely with CDMOs and Consultants to ensure timely and high-quality delivery of Drug Substance and Drug Product, managing supply distribution for clinical studies, and participation in regulatory submissions.
Key Responsibilities:
- CDMO Oversight: Select and collaborate regularly with CDMOs for drug product, drug substance and analytical support as needed to ensure that process development and manufacturing are going smoothly. Review and approve all processes including batch records, method and process validation protocols, specifications, stability protocols, etc.
- Compliance: Ensure all activities (methods, stability studies, reference standard controls, distribution requirements, etc.) and processes comply with relevant regulations (e.g., FDA, EMA, ICH), guidelines, and industry best practices, including GMP and GLP where applicable.
- Quality: Work closely with the quality team to ensure that vendors are properly qualified and compliant with the company’s standard of excellence.
- Regulatory Writing: Lead the preparation, submission, and maintenance of CMC-related regulatory filings and sections, to include IND M3, IMPD, etc.
- Collaboration: Work closely with diverse cross-functional teams, including discovery, nonclinical development and clinical development, regulatory affairs, and CRO external partners, to ensure effective and timely implementation of clinical trials.
- Study Design: Work with the nonclinical team to design chemistry studies for early development of new drug candidates, to include SAR, stability, characterization and manufacturing feasibility studies.
- Supply Management: Work with CDMOs, storage facilities, and distribution partners to ensure that supplies are available for all nonclinical and clinical studies.
- Present Study Updates: Monthly presentations in West Lafayette, IN and remote weekly management updates to company leadership regarding CMC progress updates.
- Vendor Management: Identify, evaluate, and select CROs, CDMOs, and other external partners. Manage vendor relationships, including contract tracking, budget management, and oversight of project timelines, with a strong focus on quality assurance and risk mitigation.
- Budget Management: Review and approve CMC budgets.
- Innovation: Stay abreast of the latest developments in drug development technological advancement and the evolving regulatory landscape.
Qualifications:
- Minimum of 5 years of experience in pharmaceutical process development with experience and knowledge in both drug substance and drug product programs,
- Minimum 3 years of CMC vendor oversight experience.
- Experience with regulatory submissions including INDs, IMPDs, NDAs, MAAs, or similar.
- A broad understanding of ICH guidelines, FDA requirements, and global regulations (primarlity EMA)for drug development with respect to manufacturing, analytical testing requirements and stability.
- Solid understanding of GxP policies and procedures.
- Excellent leadership, communication, and interpersonal skills.
- Ability to work effectively and make decisions in a fast-paced, dynamic environment.
- Possess the highest personal integrity and an impeccable professional reputation.
Benefits:
- Potential for remote position with up to 20% travel required, with opportunities for additional travel if desired
- Competitive salary and bonus structure
- Comprehensive health insurance
- Retirement savings plan with company match
- Opportunities for professional development and career advancement, including cross-functional development opportunities regulatory, quality, clinical, and others
- Collaborative and inclusive work environment
- Stock options available at the discretion of the board
Application Process: Interested candidates should submit their resume and a cover letter detailing their qualifications and experience to jobs@eradivir.com
