The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides
In order to continue our organic growth, we are constantly looking for talent.
The Technical Writer I will prepare cGMP documentation, including protocols, reports, studies, Failure Mode and Effect Analyses (FMEAs), memos, forms, specifications, qualifications, change controls, deviations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOPs), and Master Batch Production Records (MBPRs).
- Write and revise documentation, such as protocols, reports, SOPs and associated forms, and MBPRs
- Review and complete all documentation following cGMP guidelines
- Ensure collaboration between all applicable departments, such as Production, Facilities, Materials Management, QA and QC
- Adhere to manufacturing schedules and timelines
- Participate in the validation of products and processes
- Participate in project meetings with subject material experts
- BS Degree in Chemistry or related field
- Minimum of 1 year of work experience as a chemist or scientist in a cGMP environment or 1 year of technical writing experience
- Understanding of in-process analytical methods (e.g. HPLC)
- Comfortable working around hazardous materials and chemicals
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Detail oriented with the ability to troubleshoot and resolve problems
- Ability to work independently and manage one’s time
- Ability to communicate effectively and function well in a team environment
- Experience with peptide manufacturing and associated analytical methods
- Experience with cGMP manufacturing and documentation standards