Drive & help manage process development & manufacturing activities and resources for Purespring’s products to ensure smooth and effective transition from pre-clinical & early phase clinical proof of concept to pivotal trials and commercial launch.
Purespring is one of the first AAV gene therapy companies focused on the kidney globally. It has been founded around the seminal work of Professor Moin Saleem, Head of Bristol Renal where he heads a world leading group researching glomerular diseases. Purespring will seek to advance gene therapies for the treatment of chronic renal diseases that are currently poorly addressed with existing treatments. The Company is backed by Syncona (www.synconaltd.com), a London-listed FTSE 250 healthcare investment company founded by the Wellcome Trust.
We are building a world-class team from the ground up and are seeking an experienced Bioprocessing & Manufacturing professional to help drive the establishment, development and implementation of AAV production processes for both in-house and outsourced manufacture of AAV gene therapy products.
Experience of outsourced development & manufacturing in support of the GMP manufacture of biological products, spanning development through to Pivotal Phase III clinical material supply, is essential. Experience of commercial supply is desirable but not essential.
Experience of working with viral products is required. Experience of AAV and gene therapy products is preferable.
Many manufacturing activities are outsourced. Experience of managing out-sourced manufacture is therefore preferable.
This role will report to the VP Development.
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Job Specification
Drive & help manage process development & manufacturing activities and resources for Purespring’s products to ensure smooth and effective transition from pre-clinical & early phase clinical proof of concept to pivotal trials and commercial launch.
The position will involve the development of in-house & out-sourced activities for:
- The downstream AAV process development & optimization, following QbD principles
- Process Tech Transfer to external manufacturing partners
- Responsible for the design & execution of development work & experiments in PS’s laboratories as required to support project work
- Writing of process descriptions, protocols, experimental procedures including internal SOPs
- Data review & interpretation and final study report writing
- Reporting of results (internally and externally)
- Trouble shooting and investigations into out of specification results
- Filling, labeling, and packaging activities leading to released Drug Product (as required)
- Input into FMEAs, Process Characterisation & Validation of AAV Drug Substance and Drug Product manufacture
- Monitoring of vendor performance and delivery according to content, timelines
- Work with vendors to ensure a smooth supply of critical starting materials, as required
- Support, as needed, concurrent process analytical development activities
- Generation, review and editing of source documents and the establishment and review of regulatory filing documents.
- Liaise with Quality Control, Quality Assurance and Regulatory functions to ensure that scope, execution, and reporting meets required expectations
- Participate, as required, in regulatory inspections as client representative
- Management of shipping logistics for recombinant virus products and related materials
- Lead initiatives to identify cost savings opportunities and optimise cost of goods manufactured (COGM)
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Supply Chain
As required, work with external stakeholders to implement and manage a secure supply chain for sourcing key GMP materials to support clinical manufacture. Interface with internal stakeholders (technical leads, clinical project management and regulatory) to ensure and oversee uninterrupted clinical IMP and drug supply. Collaborate with QA on supplier qualification and supplier-initiated
change controls.
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Qualifications and Experience
- BSc in biochemical engineering, biological or pharmaceutical sciences with relevant post graduate qualification (or equivalent professional qualification or accreditation)
- 5 -10 years industrial experience in biotechnology process development ideally with GMP manufacturing environment experience
- Demonstrated development of scalable manufacturing processes, ideally for AAV based gene therapeutics
- Orphan drug development experience (desirable)
- Demonstrated outsourcing management experience (desirable)
- Supply chain management experience (desirable)
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Knowledge and Skills
- Technical expertise in process development & GMP manufacture of viral (gene) therapy products
- Excellent team & personnel interactions track record
- Experience with CMC development extending from IND to NDA/BLA, including a solid understanding of global registration processes & previous successful interactions with regulatory agencies
- Excellent interpersonal & organizational skills, project management skills & ability in problem solving
- Attention to detail with documentation and coordination/oversight practices
- Ability to prioritize multiple tasks and act decisively
- Team approach to programme management
- Able to work both independently and collaboratively in a team
- Able to influence others and lead complex projects
- Demonstrated ability to identify critical program risks and develop mitigation plans
