Expiry Date: 21-09-2021
Category Regulatory Affairs
Job Type: Full Time
Gene Therapy (GT) Process Sciences Downstream Lead - Belgium - Great package - Permanent - Digital Hiring
The GT Process Sciences Downstream Lead will build and hold accountability for a downstream process development organization for production of recombinant adeno-associated virus gene therapy products. This individual will be a people leader and will be accountable for the hiring and expansion of the downstream process development team to support the clients gene therapy programs. This role is an opportunity to build the organization and systems to drive forward the clients new gene therapy pipeline.
The Downstream Lead will leverage internal and contract laboratories to support development of downstream processes and definition of a production platform for the clients gene therapy offerings.
Role will entail:
• Acting as the downstream process development technical subject matter leader for gene therapy products supporting facility design, Quality-by-Design (QbD) process development, and pre-clinical and clinical manufacturing.
• Leading hiring efforts for the Downstream Process Sciences team against hiring plans to support planned program scope and manage the team once hired.
• Author & review technical documents including CMC regulatory sections, process descriptions, study designs, SOPs, technical position papers, & technical reports.
• Providing scientific leadership including experimental design and data analysis for the Downstream Process Sciences team internally, cross-functionally, and to partners and contract organizations (eg. CDMOs).
• Supporting development and manufacturing facility design as Process SME.
Eductaion & experience
• Master’s Degree or PhD in Chemical engineering, Bioengineering, Biology, Biochemistry, Virology or related field.
• At least 3 to 5 years of experience in biologics process development, manufacturing, engineering or equivalent.
• Excellent technical knowledge of biologics downstream manufacturing and process development (Chromatography, TFF, NFF). Experience with AAV manufacturing is desired.
• Experience hiring and onboarding direct reports.
• Very good command in French and English, both spoken and written.
• Strong people management and leadership skills.
• Ability to attract and retain talent.
• Project management, capacity modeling, and prioritization skills.
• Problem solving and drive for results.
• Interpersonal skills to communicate and maintain good working relationship with internal and external customers.
If this sounds like you and you wish to join a successful global Bio Pharmaceutical please contact me to discuss.
To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to firstname.lastname@example.org. Alternatively, please press the red “Apply for position” button and follow the registration process.
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