Associate Director, Analytical Development and Quality Control
We are currently seeking a highly motivated, experienced individual for the position of Associate Director of QC and AD. The position is responsible for supporting QC activities for Eiger projects. The ideal candidate will have demonstrated knowledge in Quality Control execution, stability program management, method qualification/validation/transfer and reference standard inventory management. The position reports to the Senior Director of Quality Control and Analytical Development.
Essential Duties and Responsibilities
- Manage method qualification/validation/transfer activities for starting material, intermediate, drug substance and drug product at CMOs
- Support timely review and QC of analytical data packages for drug substance (DS) and drug product (DP) release
- Generate release and stability specifications for starting materials, intermediates, drug substances, and drug products
- Manage DS and DP stability programs, timelines, and corresponding shelf-life determination
- Lead preparations of stability sections for regulatory submissions
- Support laboratory investigations for deviations, OOS/OOTs, determine root cause analysis and CAPAs for analytical issues
- Oversees qualification of reference materials and management of their inventory and supply across testing sites
- Support QC data management in Eiger e-QMS
- Bachelor’s degree in Chemistry, Biochemistry or a related field is required
- 8+ years of experience in pharmaceutical or biotechnology industry with at least 5 years in quality control laboratories or related quality control area
- Broad knowledge of analytical techniques including HPLC, GC, compendial methodologies etc. for small molecules and biologics
- Strong knowledge in regulatory, ICH and cGMP requirements pertaining to biotechnology and pharmaceutical industries required
- CMO based QC management experience
- Experience with IND/NDA and IMPD/MAA submissions
- Experience in late-stage drug development is preferred
- Proven track record in applying analytical techniques to solve challenging problems
- Collaborative nature required
- Very strong organizational abilities and communication skills
- Self-directed, independent
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
About Eiger BioPharmaceuticals, Inc.
Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.
Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, well-tolerated type III interferon entering Phase 3.
Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.