Formulation & Process Development

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View: 134

Update day: 25-04-2024

Location: Basel Basel-Stadt BS

Category: Human Resources

Industry: IT Services IT Consulting

Position: Entry level

Job type: Full-time

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Job content

Job Title: Formulation & Process Development

Drug Product Development Biologics & CGT

Location: Basel, Switzerland

Duration: 11 Months

Job purpose

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 & Client guidelines
Background

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

" 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.
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Deadline: 09-06-2024

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