Technical Writer
Bachem Holding AG, San Diego, CA, United States
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com .
A brief overview 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).
What you will do
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
Qualifications
Bachelor's Degree BS Degree in Chemistry or related field
Minimum of 1 year of work experience as a chemist or scientist in a cGMP environment
1 year of technical writing experience
Experience with peptide manufacturing and associated analytical methods
Experience with cGMP manufacturing and documentation standards (Preferred)
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
Base Salary Range Technical Writer I: $61,171.20-$84,110.40
Technical Writer II: $67,655.26-$93,025.98
Technical Writer III: $82,136.80-112,938.10
Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.
Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.
Please note: unsolicited resumes from recruitment agencies will not be considered.
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A brief overview 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).
What you will do
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
Qualifications
Bachelor's Degree BS Degree in Chemistry or related field
Minimum of 1 year of work experience as a chemist or scientist in a cGMP environment
1 year of technical writing experience
Experience with peptide manufacturing and associated analytical methods
Experience with cGMP manufacturing and documentation standards (Preferred)
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
Base Salary Range Technical Writer I: $61,171.20-$84,110.40
Technical Writer II: $67,655.26-$93,025.98
Technical Writer III: $82,136.80-112,938.10
Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.
Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.
Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.
Please note: unsolicited resumes from recruitment agencies will not be considered.
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