Director Process Development
3 weeks ago
A well-funded startup in the biotechnology sector specializing in ophthalmology. As a leader in developing innovative products, our mission is to protect and restore the vision of patients suffering from various eye diseases. We are expanding our Chemistry, Manufacturing, and Controls (CMC) team to support our ocular therapies into late-phase clinical trials.
Role Overview:
We are seeking an experienced Process Development Subject Matter Expert (SME) to provide insights into mammalian cell culture processes. This role will focus on technology transfer and scaling up support for late-phase clinical development and Investigational New Drug (IND) studies for multiple assets.
Responsibilities:
- Downstream Process Oversight: Manage activities at Contract Development and Manufacturing Organization (CDMO) sites, including optimization, technology transfer to Good Manufacturing Practices (GMP) environments, and Process Performance Qualification (PPQ) batches.
- Process Development: Develop and implement downstream processes that align with the company's goals and meet established regulatory requirements.
- Stakeholder Collaboration: Engage regularly with both internal and external stakeholders to ensure alignment and progress on key projects.
- Technical Scope Definition: Work closely with CDMO counterparts to define technical scopes, monitor execution, and review data from optimization studies.
- Validation Strategy Design: Design process validation strategies for manufacturing processes in collaboration with CDMOs, adhering to regulatory requirements and industry best practices.
- Risk Management: Identify potential risks to CMC processes, propose enhancements to improve efficiencies, and reduce development timelines.
Skills, Knowledge, & Experience:
- Educational Background: Bachelor’s degree in Biochemical Engineering, Biotechnology, or a related field.
- Downstream Development Experience: Extensive experience in early-stage and late-stage downstream development for complex biologics, with a strong emphasis on purification technologies applied to mammalian cell culture-based manufacturing.
- Technical Proficiency: Deep technical knowledge of downstream unit operations, including column chromatography, filtration, harvest, and viral clearance validation.
- Regulatory Knowledge: In-depth understanding of GMP regulations and guidelines related to biologics manufacturing.
- Project Management: Excellent project management skills, with the ability to effectively manage timelines and coordinate with stakeholders.
- Communication Skills: Strong ability to collaborate and communicate with a global remote team.
Location: This is a remote-based role with the flexibility to be located anywhere in the United Kingdom. However, there is an expectation to travel to the company’s site in London twice per month.
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