Chemist
$64,626–$89,606 year
On-site · US
Job Summary
Manufacture APIs in a cGMP environment and perform related activities. Install, operate and maintain equipment for manufacturing and in-process testing (HPLC/UPLC, lyophilizers, reactors, HF cleavage equipment, diafiltration systems, water purification systems, ovens, and washing systems). Conduct solid phase and liquid phase synthesis, deprotect and cleave APIs from resin using chemical cocktails (HF, TFA, ammonium hydroxide or equivalents). Purify via chromatography and crystallization; follow GMP Master Batch Records, SOPs, and Standard Test Procedures to manufacture GMP materials and perform in-process testing and packaging. Plan projects, initiate raw material orders, receive materials, coordinate with QA/QC and Material Management for material release, and monitor inventories. Maintain GMP documentation, investigate deviations, produce reports, and support quality control/assurance in calibration programs. Maintain organized work areas and contribute to SOP/MBPR/STM updates. Ensure compliance with maintenance and cleaning procedures, assist in calibration, and manage chemical waste disposal. Write and improve GMP documents and SOPs. Adapt to four 10-hour shifts (Alpha, Bravo, Charlie, Delta) with specific start times. Total rewards include competitive pay, annual performance bonus, comprehensive benefits, and 401(k) with employer contribution.
Required Qualifications
- Bachelor’s degree in chemistry or related field
- 10+ years relevant experience in lieu of degree
- Experience in using general lab instrumentation (e.g. HPLC, UV Spectrometry)
- Experience in GMP manufacturing and knowledge of cGMP and FDA regulations (preferred)
- Experience in manufacture of peptides and oligonucleotides (preferred)
- Ability to work four 10-hour shift schedules per week with start times early morning or late afternoon
- Ability to work independently and manage time
- Ability to organize, multitask, and work in a fast-paced, deadline-driven environment
- Basic computer knowledge (Microsoft Word, Excel, PowerPoint)
- Ability to work with hazardous materials and chemicals
- Excellent written and oral communication skills
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