Manager, Drug Product Development & Manufacturing

Summary:

This full-time position is part of IVERIC’s Technical Operations team. This individual will be responsible for ensuring the robust technical support of our gene therapy drug product development and manufacturing, from early development through commercialization. The individual will work closely with internal functions, including Technical Operations, Regulatory, and Quality, as well as external Contract Manufacturing Organizations (CMOs) to ensure all aspects of technology transfer and technical support are successfully executed. This position will report to the Director, Drug Product Development and Manufacturing.

Responsibilities:

• Leads formulation development, dosage design, tech transfer, process design, and process characterization for gene therapy drug products. Develop product presentations to meet TPP and LCM requirements
• Supports cGMP manufacturing including authoring of technology transfer document (TTD), reviewing batch record, providing PIP, monitoring/ analyzing process data, investigating manufacturing issues, and supporting deviation closeout
• Manages external CROs/CMOs for development and manufacturing activities. Drive the technology transfer process to GMP manufacturing facilities efficiently and effectively
• Collaborates closely with various teams including Upstream and Downstream, Analytical, Quality, Supply Chain, Clinical, and Regulatory
• Familiar with applicable global regulations and industry standards. Author drug product sections to support regulatory filings
• Understands the Intellectual Property landscape in the gene therapy field and leads IP development for gene therapy formulation development.
• Travel requirement ~10-30%

Skills / Knowledge Required:

• Biochemical engineer, chemical engineer, or biochemistry background. BS with 3-8 years, MS with 1-5 years, or PhD with 0-3 years of product development experience in a pharmaceutical or biotechnology company
• Gene therapy/ Biologics product development experience in one or more of the following aspects: formulation screening, dosage forms, characterization, primary container system, extractable/ leachable, clinical in-use, label/ packaging, and cold chain management
• Process development or cGMP operational experience in one or more of the following bioprocessing unit operations: Purification, tangential flow filtration, buffer formulation, drug product compounding, and aseptic fill/finish (liquid and/or lyo)
• Experience in gene therapy/ biologics technical transfer to CMO is preferred
• Knowledge of data management tools and statistical analysis is a plus
• Knowledge of cGMP equipment, process, and facility is preferred
• Understanding of the Intellectual Property landscape for the field
• Demonstrated ability for critical thinking and innovation
• Proficient in oral & written communication skills
• Able to understand and communicate risks, and develop and execute contingency plans