GMP Chemist: API Manufacturing & Lab Operations

Bachem; Torrance (CA); On-site; USD 43,000 - 82,000; Full time

Benefits offered by this job

Competitive pay

Annual performance bonus

Medical/Dental/Vision coverage

Job summary

Bachem Americas in Torrance, CA, is seeking a Chemist to manufacture active pharmaceutical ingredients (APIs) in a cGMP environment. You will install, operate and maintain manufacturing equipment, perform synthesis, purification and in-process testing, and ensure adherence to GMP master records and procedures.

The role requires GMP experience, lab instrumentation expertise (HPLC/UV), and the ability to work four 10-hour shifts starting as early as 5:00am or as late as 3:00pm, including weekends.

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)
• 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 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

Responsibilities

• 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

Skills

Attention to detail

Excellent communication

Team collaboration

Problem solving

Microsoft Office

Education

Bachelor’s degree in chemistry

10+ years relevant experience in lieu of degree

Tools

HPLC

UV Spectrometry

Job description

Bachem Americas in Torrance, CA, is seeking a Chemist to manufacture active pharmaceutical ingredients (APIs) in a cGMP environment. You will install, operate and maintain manufacturing equipment, perform synthesis, purification and in-process testing, and ensure adherence to GMP master records and procedures.

The role requires GMP experience, lab instrumentation expertise (HPLC/UV), and the ability to work four 10-hour shifts starting as early as 5:00am or as late as 3:00pm, including weekends.