Bachem Holding AG
Your Responsibilities The Technical Writer will prepare technical protocols and associated technical reports for all manufacturing stages including synthesis, cleavage, purification and lyophilization. The Technical Writer will also be responsible for writing technical procedures such as Standard Operating Procedures (SOP`s), Master Batch Production Records (MBPR), and other documentation following cGMP guidelines. Your Tasks Write technical protocols and associated technical reports for all manufacturing stages including synthesis, cleavage, purification, and lyophilization Write technical procedures, such as Standard Operating Procedures (SOP`s), Mater Batch Production Records, and other documents following cGMP guidelines Review and complete cGMP documentation following cGMP guidelines Ensure collaboration between the Production department and other supporting departments such as Operations, Materials Management, QA and QC Adhere to manufacturing schedules and timelines Propose technical improvements in documentation Participate in the development of the new paradigm for validation Perform experiments for the new process justification Participate in improving the quality of documentation in all peptide manufacturing stages following cGMP guidelines Participate in project meetings including the weekly Production and R&D meetings Your Profile Required BS Degree in Organic Chemistry or related field Minimum of 3 years` work experience as a chemist or scientist in a cGMP environment or 3 years` technical writing experience Proficient with various in-process analytical methods Experience with cGMP manufacturing and documentation standards May work with 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 Communicate effectively and ability to function well in a team environment Preferred Master`s in Organic Chemistry or related field Experience with peptide manufacturing stages and various in-process analytical methods Experience with cGMP manufacturing and documentation standards We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.
Bachem Holding AG
Website : https://www.bachem.com
Bachem is an independent, technology-based, public biochemicals company providing full service to the pharma and biotech industry. Bachem is specialized in the process development and the manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients (APIs), as well as innovative biochemicals for research purposes. With headquarters in Bubendorf, Switzerland, and affiliates in Europe and the US, Bachem works on a global scale and holds a leading position in the field of peptides.