Beschreibung
Our client, a global leading biopharmaceutical company, requires multiple Process Formulation Leads to join their Biologics R&D late phase team.Responsibilities
• In this role you will develop formulations and manufacturing processes for parenteral dosage forms of biologics for the clinic, market and for lifecycle products.
• You will be responsible for transfering the manufacturing process to the clinical and commercial manufacturing site internally or externally.
• As the subject matter expert for pharmaceutical development, you will represent pharmaceutical development in the technical CMC teams of the assigned project.
• You will work closely with your colleagues in pharmaceutical operations, device development, analytics and quality.
• You will represent the client externally at scientific meetings, giving talks, joining industry consortiums, publishing papers etc.
• You will support technology evaluations as requested and proactively identify and realise opportunities for Invention Disclosures in portfolio and technology projects assigned.
• You will support the assigned due diligence activities.
Key requirements
• PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline.
• Extensive experience in the pharmaceutical development of biologics (formulation & manufacturing process), preferably in late phase development.
• Hands-on experience in transferring manufacturing processes.
• Understanding of quality control (cGMP) including production aspects.
• Excellent communication skills.
• Experience in filings with health authorities, preferably with BLAs/MAAs.
• Experience in design of experiment (DoE) and using statistical program.
• Demonstrated ability to work in interdisciplinary technical teams.
• Good organisational skills.
• Ability of scientific and entrepreneurial thinking.
• Excellent English required (oral & written); good skills in German is beneficial.
These positions are long-term assignments, seeking the best available interim consultants, if this is of interest please contact me.
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