Eiger Biopharmaceuticals is a clinical-stage biopharmaceutical company committed to developing and commercializing novel products for the treatment of Orphan diseases. Eiger has built a diverse, late-stage portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, a novel biology for treatment has been identified, and for which an effective therapy is urgently needed. The Eiger management team has extensive experience in the clinical development and commercialization of a broad range of therapeutics, with special expertise in Orphan Designation drugs. Eiger is located in Palo Alto, California.
- Responsible for ensuring that all investigational and potential commercial drug substances and drug products are manufactured in accordance with applicable regulatory filings and in compliance with cGMP.
- Ensure timely review, release and disposition of drug substance, intermediates and investigational products.
- Approve and issue all CMC specifications.
- Review and approve validation protocols and reports as applicable for all manufacturing, testing, and packaging activities at CMO's.
- Oversee GCP compliance with respect to clinical site and CRO audits.
- Work with CMC, Non-Clinical, Clinical, Regulatory as an active cross-functional team member to ensure the appropriate documentation integrity for regulatory submission and vendor PAI readiness.
- Manage all quality system including SOPs, deviations, CAPAs, and complaints.
- Maintain quality documentation control of files, databases and logs.
- Oversee qualification, performance tracking, and reviews of contract manufacturers and laboratories and manage Technical Quality Agreements and external audit programs.
- Acting as the main point of contact on all quality matters, internally and externally.
- At least ten (10) years of experience in management of Quality, Regulatory and/or Manufacturing functions in the pharmaceutical and/or biotechnology industries.
- Bachelor's Degree in a scientific discipline
- Detailed understanding of the pharmaceutical business, especially clinical development and manufacturing.
- Strong leadership/team management skills and experience.
- Credible and confident communicator (written and verbal) at all levels.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Proficient with MS Word, Excel and PowerPoint