Head of Bioprocess Development & Manufacturing

Hobson prior are seeking a Head of Bioprocess Development & Manufacturing to join our client on a permanent basis located in London. Our clients mission is to develop treatments for patients by working closely with high class academic founders.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Upstream and downstream AAV process development & optimization, following QbD principles.
• Process Tech Transfer to external manufacturing partners.
• Management, development and supervision of 1-3 scientific staff.
• Expectation of hands on involvement in PS's laboratories as required to support project work.
• Filling, labelling, and packaging activities leading to released Drug Product.
• Review and sign-off of process descriptions & protocols.
• Data review and sign-off of final study reports.
• Reporting of results (internally and externally).
• Trouble shooting and investigations into out of specification results.
• Process Characterisation & Validation of AAV Drug Substance and Drug Product manufacture.
• Monitoring of vendor performance and delivery according to content, timelines and budget.
• Support, as required, concurrent analytical and bioanalytical 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).

Key Skills:

• 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.

Requirements:

• BSc in biochemical engineering, biological or pharmaceutical sciences with relevant post graduate qualification (or equivalent professional qualification or accreditation).
• 10+ years industrial experience in biotechnology process development & GMP manufacturing environment.
• Demonstrated process development of scalable manufacturing processes experience.
• Demonstrated outsourcing management experience.
• Experience with viral or gene therapy products and production.
• Orphan drug development experience (desirable).
• Supply chain management experience.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.