Senior Director, Product Development

Company: Eiger BioPharmaceuticals, Inc.
Location: Palo Alto
Posted on: January 15, 2022

Job Description:

The Senior Director of Product Development will be responsible for all aspects of formulation and process development from DOEs, process development, technology transfer/scale up and process validations for drug products, devices and commercial manufacturing. The Senior Director will also serve as CMC Lead of Eiger products and projects with the responsibility of authorship of the CMC sections of global regulatory submissions for both clinical and to be marketed products. This role is a broad-based, strategic position requiring an established leader with in-depth scientific and technical knowledge of biological product development.

Responsibilities include, but not limited to:
Provide strategic oversight on product development activities including formulation, process development, process characterization, scale-up, technology transfer and process validation
Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions.
Serve as SME and participate in strategy guidance for CMC related regulatory interactions
Collaborate effectively with Quality to ensure compliance with GMP guidelines at all times and make recommendations to ensure conformity with quality specifications.
Oversee and manage process characterization and process validation studies, as well as technology transfer for all phases of development and commercial products.
Manage external CMO activities, ensuring close partnership through open and transparent communications, scientific and strategic understanding, and attention to Eiger priorities
Apply sound scientific and engineering criteria to design and develop manufacturing processes, identify and execute process improvement / optimization strategies, and ensure successful commercial scale-up for all programs
Lead CMC projects and represent CMC in Project Development meetings, as required
Develop resourcing strategies, allocate budget for department to meet company objectives and efficient operations
Author of and/or reviews batch records, change controls, process validation and other technical documents.

Minimum Skills/Knowledge Required:
Ph.D., M.Sc. or B.Sc degree in Biotechnology or other relevant life science discipline with at least 12 years' relevant industry experience, with at least 5 years' experience in a Product and Process Development role.
Experience participating in and leading cross functional teams.
Experience interfacing with internal operations groups and/or contract manufacturing organizations.
Knowledge and broad understanding of the CMC approaches, including cGMP operations requirements and relevant regulatory guidelines.
Excellent written and verbal communication skills.
Ability to work in a fast-paced environment, to multitask and manage multiple projects.
Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

EOE

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, type III, well-tolerated 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

Please submit your resume to:
Careers@eigerbio.com

Keywords: Eiger BioPharmaceuticals, Inc., Palo Alto , Senior Director, Product Development, Executive , Palo Alto, California