Install, operate and maintain equipment for manufacturing and in-process testing (HPLC/UPLC, lyophilizers, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, ovens, washing systems, et al.)
Perform solid phase and liquid phase synthesis, deprotect and cleave the API from the resin using chemical cocktails, containing HF, TFA, ammonium hydroxide or other chemicals
Perform purification process via chromatography, crystallization and other techniques
Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities
Perform project-planning and initiate raw material order-request. Receive raw materials, coordinate with QA/QC and Material Management for material release and monitor raw material inventories
Follow and maintain GMP Documentation System; Investigate deviations and produce reports; Initiate document change request; Assist quality control and assurance unit to maintain equipment calibration program
Maintain/organize work areas (hood, bench, floor, wall, etc.) and other designated areas within the manufacturing facility
Write and improve Standard Operation Procedures (SOP), Standard Test Procedures (STM), Master Batch Records (MBPR) and other related GMP documents
Follow SOPs and approved directions to clean equipment used in GMP processes, maintain cleaning log for each equipment, assist in equipment calibration program, and dispose chemical waste generated in the manufacture
Monitor compliance of maintenance and cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment
Qualifications
Bachelor’s degree in chemistry or related field (in lieu of degree, will consider 10+ years relevant experience)
Experience in using general lab instrumentation (e.g. HPLC, UV Spectrometry)
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Experience in GMP manufacturing as well as basic knowledge of cGMP and FDA regulations (preferred)
Experience in the manufacture of peptides and oligonucleotides (preferred)
Capable of following GMP guidelines and housekeeping rules
Excellent written and oral communication skills
Communicate effectively and ability to function well in a team environment
Ability to communicate in a proactive and solution-focused manner, including keeping direct supervisor aware of potential issues.
Ability to accommodate four 10-hour shift schedules each week with start times as early as 5:00am or as late as 3:00pm (including either a Saturday or Sunday)
Ability to work independently and manage one’s time
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Detail oriented with the ability to troubleshoot and resolve problems
Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
Ability to work with hazardous materials and chemicals
Placement of new hires in these wage ranges 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.
About Bachem
Pharmaceuticals & Biotech1,001-5,000Founded 1971
Bachem is a Swiss contract development and manufacturing organization (CDMO) specializing in peptides and oligonucleotides for pharmaceutical and biotechnology companies. Founded in 1971 and headquartered in Bubendorf, it supports research, clinical development, and commercial applications through sites in Europe, the United States, and Asia.
