Description
We are looking for a
CMO Specialist (m/f)
Reference: -en
Start: asap
Duration: 4 MM
Place: in Basel
Branch: Pharmazeutische Industrie
Your tasks:
- Provide technical support to contract manufacturers
- Develop and maintain manufacturing instructions for EEM governed APIs
- Work with cross-functional groups to troubleshoot issues arising at CM sites, including but not limited to deviations
- Maintain an appropriate presence during manufacturing
- Review process and product data for adverse trends
- Assess and understand process capability
- Act as primary technical point of contact for the manufacturing process
- Identify, evaluate and implement process improvements with a focus on capability, compliance and cost
- Conduct/support process validation
- Review and/or approve Annual Product Quality Reviews (APQR)
- Participate in the evaluation of the commercialisation of new products through due diligence, product reviews and cost modelling
- Support the commercialisation of new products by partnering with R&D colleagues in the later phase of the development process
- Ensure manufacturing concerns are addressed at phase-appropriate points of development, effectively apply principles of QbD as applicable
- Facilitate the manufacturability review process
- Support the identification, selection, and approval of contract manufacturers
- Lead technical transfer, process implementation and validation activities
- Support launches in secondary markets, ensure regulatory commitments are aligned with process capabilities
Your qualifications
- Higher science degree (e.g. in Engineering, Chemistry, Biochemistry) or Bachelor of Science degree with relevant work experience
- relevant prior pharmaceutical manufacturing experience, specifically regarding drug substances
- Understanding of cGMP requirements for drug substances and drug product manufacturing
- Strong problem solving skills, including strategic and creative thinking
- Clear and concise communication skills (both written and verbal)
- Cross-functional networking skills, demonstrated persuasion skills
- Product commercialisation experience
- Understanding of or experience in multiple technology platforms (small molecule, large molecule, oral solid dose, liquid formulations etc.)
- Understanding of analytical methods
- Working knowledge of Regulus and Trackwise
Skills:
- Quality manager
Keywords: Qualitätsmanager