Technician, GMP Production

CSBio; Milpitas (CA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k with 1:1 match

PTO 10 days

Job summary

CSBio is a peptide contract manufacturer with facilities in Menlo Park and Milpitas, CA, seeking GMP Production Technicians. You will be responsible for synthesis and cleavage or purification and freeze-drying of peptides in GMP manufacturing areas.

Key duties include executing batch records, analyzing compounds, and maintaining data accuracy in a clean, compliant environment. The role requires the ability to read work orders, prepare solutions, and contribute to lab cleanliness.

Qualifications

• Knowledge of GMP manufacturing and batch records is required.
• Experience with synthesis and/or purification of peptides preferred.
• Ability to work in GMP clean rooms and follow SOPs.

Responsibilities

• Perform GMP synthesis or purification of peptides in manufacturing areas.
• Operate and maintain lab equipment (HPLC, mass spectrometers, freeze dryers, centrifuges).
• Record data on standardized forms and ensure accuracy.
• Work in Menlo Park or Milpitas facility as assigned.

Skills

GMP knowledge

Synthesis

Purification

Lab equipment

Mass spectrometry

HPLC

Tools

HPLC

Mass spectrometry

Centrifuges

Freeze dryers

N2 tanks

Job description

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 Technican 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.

Able to work on Saturdays and/or Sundays

Ability to work independently and as part of a team

Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)

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

Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).

Disability insurance 50% standard employer paid.

Carpool, clean air vehicle, and cell phone reimbursement

Employee rewards and recognition program

Company organized social events

Quarterly sponsored team building activities

CSBio is a premier manufacturer of automated peptide synthesizers and custom peptides, serving the global pharmaceutical industry for over 30 years from Silicon Valley.

Biotechnology Research Research Services Professional Services

20 Kelly Ct., Menlo Park, CA 94025, US 915 Linda Vista Ave, Mountain View, California 94043, US 801 Buckeye Ct, Milpitas, California 95035, US