Head of IMP Manufacturing - Viral Vectors
Background on Role
This is a rare opportunity to join a well-known and established Biotech company near the beginning of their R&D ramp-up to support several Viral Vector therapies coming into development as one of the core team spearheading the manufacturing for their translational medicine Viral Vector assets.
The company is not an incubator, they are a full research-based bio-pharmaceutical company with many successful marketed products and were one of the first to register a mAb many years ago! The organization has the assets to give you real projects to activate on, and have a specific timeline for their first IMP in clinic so you will be joining to build a matrix team worldwide, with analytical capabilities being hired as we speak in one of their R&D sites.
First 12 Month Focus
This is a really pivotal role as you will build the roadmap through strong technical and people leadership to show the organization the “How To’s” for manufacturing IMPs, and then the “What is needed?” - advocating for investment internally, with associated planning and co-creation of costs, as well as the establishment of a robust network for the supply of CDMOs for pure Virally Vectored rAAVV IMPs in the meanwhile (as later, you will lead the company to develop the platform in-house).
You will have oversight for the IMPs through transfer in / out of CDMOs and, as you will be part of the team establishing internal capacity, you will co-develop with other senior stakeholders the plans for CapEx and associated decision-making to distinguish what could / should be done in-house Vs externally to leverage internal resources where they are needed most, reduce risk, and support better scale-up and GMP capability.
You will lead the sub-teams for both operational delivery (of robust and to quality / yield clinical trial materials into Phase 1 and 2 studies) before leveraging a footprint you will have co-developed to scale-up for Ph 3 manufacture, and co-lead the MSAT (CMC plus) teams to deliver BLA submissions, and provide the technical leadership to bring the Site through validation and the company into full GMP commercial manufacturing.
There are opportunities within GMP and Clinical Manufacturing for you to grow substantially based on your long-term delivery and leadership!
Your Experience & Skills
Experience-wise, you will be a manufacturing SME who has experience of up/downstream processes for biologicals gained over a number of years, possibly before moving into Viral Vector manufacturing in the last 2 or so years.
Earlier in your career you will have ideally co-managed or participated in a Ph 3 scale up, and now can translate this knowledge in scale-up for a Virally Vectored IMP
You will have clear experience in technical transfers for Viral Vectored products, whether this is from a CDMO or from working with a biotechnology company
Ideally, you will be able to demonstrate in your career involvement in bringing new facilities on-line, and through validation processes
You will be regulatory aware / competent and understand what the EMA and FDA require for Genetic Medicines in both IMPD and / or NDA/BLA and MAA Module 3’s
You are willing to work in Belgium post-Covid!
You will most likely have a higher Degree in Bio-/Chemical Engineering or a Biochemistry related Degree with a background in leading teams and providing expertise early on in Biological products and more r3ecently with Adeno-Associated Viruses or Leni Virals.
Support Pre-/Post-Covid (Location & Eventual Relocation)
My client has a digital hiring and on-boarding process during Covid, and this role has been given a big priority, so you will be able to be offered, hired and onboarded in your host country working remotely until travel restrictions are lifted.
Post-Covid, my client offers non-Belgium nationals / residents private schooling (policies do apply) for non-native speakers, a fully expensed and taxed relocation package including temporary house / apartment, as well as a strong annual package, including stock plan, bonus, car and petrol card, as well as a tax minimization package where applicable.
You can be an EU Member State or BlueCard worker, in Europe, or a European working in the USA who would like to return to Europe.
Applications are invited from Senior Managers, Associate Directors and Director level candidates who want to help build the future of Gene Therapy in a company which is highly innovative and has much of their science in-house.
To learn more and apply for this role, please send your CV with a covering note to firstname.lastname@example.org. You can also contact Javier Monfort or Matt Greig on +44 (0)207 801 3385 or +44 (0)207 801 3386 for an initial discussion about the role and other projects.
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