Technician, GMP Production

Gmp Production Technician

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

We are seeking qualified individuals to join us as GMP Production Technician at our Menlo Park and Milpitas facility. This position will be responsible for the synthesis/cleavage of peptides OR the purification/freeze drying of peptides in our GMP manufacturing areas. Core duties and responsibilities include the following:

GMP Synthesis

Execute batch production records or protocols for synthesis and cleavage processes with minimal supervision in a timely and efficient manner

Analyze organic and inorganic compounds to determine chemical and physical properties

Conduct research on manufactured products to develop and improve product quality

Perform data analysis and review of data for accuracy and completeness

GMP Purification

Identify the fully protected 20 amino acids batch by batch in terms of solubility and appearance

Operate laboratory equipment and instruments including: HPLCs, centrifuges, freeze dryers, stir plates, lab balance, mass spectrometers, sonicators, vacuum ovens, N2 tanks, etc.

Record purification and other experiments on standardized forms

Check analytical HPLC and mass of dissolved crude peptides properly

Identify target peptide peak by integration and mass spectrometry

Both

Read work orders thoroughly and have a good understanding of instruction and specification of final products.

Prepare and label chemical solutions according to standard formulas.

Maintain a clean working environment and contribute to overall lab cleanliness.