Technical Development Leader
- Minimum: Master in chemistry, biology, bioengineering or pharmacy, Preferred: Ph.D.
- 10+ years in upstream or downstream + a 2nd technical development area among: primary, secondary or analytical development.
- Proven experience in Late or Early process development and process transfer.
- Knowledge of Vaccine manufacturing environment
- Experience with CMC data consolidation or GMP regulations
- 5+ years in transversal function or team management
- Other skills: Strategic thinking, Communication, Presentation skills, Synthesis capacity, Spoken & written English, Negotiation, Facilitating, Influencing, Project management, Flexibility (mental agility), Mobility
- In line with the R&D strategy, the Technical Development Leader defines, leads and transversally coordinates the technical development from early phase I up to commercial launch.
- Define the product technical development strategy
- Ensure the definition of the technical product profile
- Integrate all technology and analytical aspects
- Integrate commercial constraints
- Integrate early & late development (incl. Quality by Design) and manufacturability aspects
- Ensure the continuity in process knowledge
- Bring vaccine production expertise within the project
- Ensure the transfer of expertise to GMP units representing all technologies
- Address the process fine tuning once running in GMP units
- Ensure product expertise during technical transfer and the commercial manufacturing launch
- Perform the Process Validation
- Consolidate technical data for RA files and provide product expertise for the file submission and review
- Accountable for the establishment of a comprehensive development strategy (incl. the definition of the Technical Product Profile) and plan
- Negotiate with TRD Function heads the resources allocation and development activities to achieve the target
- Challenge and adjust technical development & strategy on a weekly basis with key members of the Technical Development Team
- Identify risks on technical feasibility, timing and resources constraints and seek a remediation plan for identified risks. Escalate any technical issues (process and/or analytical ) to the relevant body
- Provide input to a monthly progress status
- Drive the execution of all development activities within the frame and organization of the IVP (Integrated Vaccine Plan) via a multi-disciplinary Technical Development Team (TDT) composed of all relevant TRD department functions + R&D preclinical + QC + RA representatives
- Accountable for all the operational development activities of the Drug Substance (from raw material to purified bulk) and coordinate the operations of the Drug Product (from formulation to the packaging operations).
- Adjust Budget & FTE needs per project
- Be the technical development representative of the Project Team and contact for the manufacturing strategy
- Lead process and analytical transfer to manufacturing up to successful launch
- Accountable for the redaction & quality of the evidences according to the different stage gates
You may apply for this position online by selecting the Apply now button.
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