Description
Very interesting and challenging position within International Pharmaceutical Company, looking for a freelance (temporary) Formulation Lead specialist for a 12 month project.Job Description:
- As a member of the Biologics Process R&D late phase team,you will develop formulations and manufacturing processes for parenteral dosage forms of biologics for the clinic, market and for lifecycle products.
- In this role you will be responsible to transfer 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 company externally at scientific meetings, giving talks, joining industry consortiums, publishing papers etc.
- You will support technology evaluations as requested and proactively identify and realize opportunities for Invention Disclosures in portfolio and technology projects assigned.
- You will support the assigned due diligence activities.
Requirements:
- PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline
- At least 5 years of experience in the pharmaceutical development of biologics (formulation & manufacturing process), preferably in late phase development
- Hands-on experience in transferring manufacturing processes
- Experience in filings with health authorities, preferable with BLAs/MAAs
- Understanding of quality control (cGMP) including production aspects
- Excellent communication skills
- Experience in design of experiment (DoE) and using statistical program
- Demonstrated ability to work in interdisciplinary technical teams
- Good organizational skills
- Ability of scientific and entrepreneurial thinking
- Excellent English required (oral & written); good skills in German as site (local) language desired (oral)
If you are interested in the described position, please contact me:
Marina Petrovic
m.petrovic [at] realstaffing.com