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Bachem

Develops and manufactures peptides and oligonucleotides

Downstream Process Expert - Isolation, API Production Site Development

Bioprocess & BiomanufacturingPosted on Sep 28
Full-timeStein, SwitzerlandNo salary listedIn-person

About the Job

Requirements

  • A PhD in Chemistry, Pharmaceutical Chemistry, or a related scientific discipline is required.
  • Several years of experience in API downstream processing, especially isolation processing, within a GMP-regulated environment is required.
  • Experience in the planning, construction, commissioning, start-up, or expansion of pharmaceutical manufacturing facilities is required.
  • In-depth knowledge of freeze and spray drying is required.
  • Strong knowledge of chemical process engineering, equipment and facility design, and relevant regulatory requirements, including ICH Q7, FDA, and EMA, is required.
  • Experience with process control systems and recipe configuration is required.
  • Fluency in German and English, both written and spoken, is required.
  • A structured, solution-oriented approach to complex engineering challenges is required.

Responsibilities

  • Provide technical leadership for establishing, commissioning, and further developing downstream freeze and spray drying processing operations for API manufacturing.
  • Support the planning and design of manufacturing equipment, facilities, and production areas, including developing technical specifications and process concepts.
  • Develop, implement, and continuously improve GMP-compliant downstream isolation manufacturing processes.
  • Prepare, review, and maintain technical documentation, SOPs, and risk assessments.
  • Provide technical support during commissioning, start-up, and the operation and optimization of manufacturing equipment and processes.
  • Troubleshoot process- and equipment-related issues and drive sustainable improvement measures.
  • Collaborate closely with TechOps, Engineering, QA, Operations, and Project Management.
  • Support regulatory inspections and customer audits and contribute to operational excellence initiatives.
  • During the project phase, support planning, design, commissioning, and start-up of manufacturing facilities and processes, ensuring GMP-compliant implementation.
  • Once operations are established, take technical ownership of downstream processes and drive continuous improvement and operational excellence.

Desired Qualifications

  • Knowledge of SPPS is an advantage.

About the Company

Bachem

Develops and manufactures peptides and oligonucleotides

Bachem provides development and manufacturing of peptides and oligonucleotides for research, clinical development, and commercial products. Its offerings include custom synthesis and scale-up production, analytical testing, and related services across the drug development spectrum. Customers work with Bachem by specifying desired sequences and specifications, after which Bachem designs, synthesizes, and quality-controls the peptides or oligonucleotides and delivers them in appropriate scales and formats. The company differentiates itself through more than five decades of experience, a global footprint with sites in Europe, the US, and Asia, and an integrated set of services spanning discovery support to commercial manufacturing. Its goal is to help pharmaceutical and biotechnology companies advance peptide- and oligonucleotide-based therapies by providing reliable, scalable, and well-supported manufacturing and development capabilities.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Bubendorf, Switzerland
Founded
1971

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