Technical Author Peptide Manufacturing (a), 100% (Temp. 12 months)

Technical Author Peptide Manufacturing (a), 100% (Temp. 12 months) #

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With a comprehensive range of services, Bachem offers pharmaceutical and biotechnology companies worldwide products for research, clinical development, and commercial application. Headquartered in Switzerland with locations in Europe, the USA, and Asia, Bachem operates internationally and possesses more than 50 years of experience and industry-wide unique expertise. The company is listed on the SIX Swiss Exchange. Further information at: www.bachem.com

To strengthen the existing team in our drug production, we are looking for a committed Technical Author Peptide Manufacturing (a), 100% (temporary for 12 months with the prospect of permanent employment) at the earliest possible date.
You are responsible for writing production-relevant GMP documents and are specialized in one production unit (manufacturing cluster) in this role.

Your tasks

• Drafting, updating, and optimizing manufacturing instructions (MBPRs), SOPs, logbooks, and risk analyses (FMEAs) for the Peptide Manufacturing area.
• Ensuring formal and content-related document quality according to GMP as well as internal guidelines.
• Implementation of changes to Master Batch Records (MBRs) in the MES (PAS-X) in close cooperation with the producers.
• Further development and harmonization of document templates and standards to increase efficiency in document creation.
• Close cooperation with the assigned Peptide Manufacturing cluster and building a sound understanding of manufacturing processes, equipment, and procedures.
• Active participation in process coordination, shopfloor walks, as well as exchange with operators, production leaders, and chemists to ensure precise and practical documentation.
• Compliance with all relevant GMP, HSE, and compliance requirements.
• Ensuring the correct implementation of requirements in manufacturing instructions, SOPs, and risk analyses.
• Support during internal and external audits by providing relevant documents and information.
• Active participation in strengthening the GMP and HSE culture in the team and the production environment.

Your profile

• Completed university degree in chemistry with a doctorate or a degree in natural sciences supplemented by professional experience in the pharmaceutical environment
• German at native speaker level as well as excellent English skills
• Proficiency in common MS Office tools
• Interest and enjoyment in creating production-related GMP documents
• Interest in practical processes in production operations
• Ability to present complex chemical processes and technical contexts in an understandable manner
• Precise way of working
• Ability to work independently or in a team depending on the situation
• Strong communication and coordination skills
• Interest in learning to create Master Batch Records (MBR) in the Manufacturing Execution System (MES) of Bachem (PAS-X), or experience in MBR design in an MES is advantageous

Our offer:

• A dynamic and strongly growing work environment with internal development and training opportunities
• Flexible working hours with the possibility of home office and the option to take additional vacation days with a reduced workload
• Internal company KITA on the Bachem Campus Bubendorf
• 60% coverage of pension fund contributions by Bachem AG as well as the possibility for extra-mandatory provision with our optional savings plan
• Access to benefit platforms with discounts at external partners
• Fresh, healthy, and diverse food in our staff restaurant
• Diverse free sports activities on the Bachem Campus

Would you like to drive innovation forward together with us?

Have we aroused your interest? Then we look forward to receiving your complete application documents via our application portal.

Learn more about the Bachem Group and let yourself be inspired by our inspiring working environment at our location in Bubendorf!

At Bachem you will find a diverse, multicultural team. (a) in the job title stands for everyone. We look forward to applications from all people. Skills and motivation count - completely independent of age or gender, origin, religion, or sexual orientation.

Note: Applications from recruitment agencies will not be considered.

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