Technician, GMP Production

Job Description

Job Description

Yowei Therapeutics and Yowei Oncology are stealth-stage life-sciences companies working closely with CSBio to advance peptide-based clinical programs. Their work spans longevity and peptide therapeutics, clinical trials, evaluation of a 503A pharmacy model, personalized synthetic neoantigen peptide oncology programs, and supporting microbiology and laboratory capabilities. Together, they are building the clinical, pharmacy, data, laboratory, and operational infrastructure needed to responsibly translate peptide programs into patient-facing studies and services. Both companies expect to remain in stealth through Q1 2027.

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

We are seeking qualified individuals to join us as GMP Production Technician. 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.

Requirements

• Able to work on Saturdays and/or Sundays
• Excellent communication skills
• Ability to work independently and as part of a team

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities