For our customer located in Basel/Switzerland we are currently looking for an: Expert in Formulation & Process Development – Drug Product Development Biologics & CGT (m/f/x)
Gross Rate Range (given by client): 40.37 – 45.41 CHF/h gross
To develop our growing pipeline of products we are looking for an experienced professional in the area of Drug Product Development Biologics & CGT. As a member of the team, you will play a key role in the development of formulations and processes for parenteral dosage forms for proteins from early phase for clinical supply to commercial use.
Tasks & Responsibilities
- Plan, organize, perform and document scientific experiments as drug product functional lead in collaboration with drug product project leads and other team members.
- Develop phase appropriate liquid of lyophilized formulations for biologics, e.g. by using high-throughput methods for biophysical characterization and standard drug product specific analytical methods
- Develop efficient and robust processes for the manufacture in sterile facilities, e.g. by applying down-scale models for critical process steps.
- Provide raw data documentation, evaluation and results interpretation.
- Propose and provide input for the design of next experiments.
- Generate scientific documents to hand over to internal partners (Manufacturing sites, Device Development, RegCMC, Clinics etc.).
- Generate lab procedures, reports and/or instructions
- Actively transfer procedures/instructions to GMP production facilities, including troubleshooting.
- Communicate and address problems, perform literature searches
- Evaluate new lab equipment.
- Contribute to maintenance of infrastructure/equipment.
- Actively participate in project teams/meetings/networks
- Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC guidelines
- Fluency in English required (oral & written)
- Degree in Biotechnology, Biochemistry, Biochemical Engineering, Pharmaceutical Sciences or a related discipline (M.Sc. or equivalent, BSc with ? 2 years industry experience, , lab technician with ? 8 years industry experience and relevant on the job training)
- Experience with parenteral dosage forms, protein formulation and analytics, and experience with aseptic working techniques and process development is a plus
- Working knowledge of various data analysis and visualization tools (JMP, Spotfire etc.) is desirable
- Excellent organizational skills with respect to planning, tracking, priority setting and adherence to project timelines.
- Excellent communication, presentation and scientific/technical writing skills.
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.