Expert in Formulation & Process Development – Drug Product Development Biologics & CGT (f/m/o) 80-100%

For our client, a renowned pharmaceutical company based in Basel, we are seeking a:

Expert in Formulation & Process Development – Drug Product Development Biologics & CGT (f/m/o) 80-100%

Background:

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.

Major accountabilities:

• 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 & internal guidelines

Minimum requirements:

• 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