Technician, GMP Production

CSBio; Milpitas (CA); Presencial; USD 32.000 - 47.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical, dental, and vision insurance

401k with company match

PTO 10 days

Company holidays

Life insurance

Disability insurance

Commuter benefits

Employee rewards program

Resumo da vaga

CSBio in Milpitas, CA, with a Menlo Park site, seeks GMP Production Technicans to support peptide synthesis and purification in our GMP manufacturing areas. You will follow batch records, operate HPLC and other lab equipment, and ensure data accuracy while collaborating with the manufacturing team.

Candidates should be able to work weekends, communicate effectively, and work both independently and as part of a team to maintain high quality standards in a cGMP environment.

Qualificações

• Able to read and follow batch production records/ protocols.
• Excellent communication and teamwork skills.
• Willingness to work Saturdays and/or Sundays.

Responsabilidades

• Execute batch production records for synthesis and cleavage with minimal supervision.
• Analyze organic and inorganic compounds to determine properties.
• Conduct research to improve product quality.
• Perform data analysis and review data for accuracy and completeness.
• Identify amino acids batch by batch during purification.
• Operate HPLCs, centrifuges, freeze dryers, mass spectrometers and related lab equipment.
• Record purification experiments on standardized forms.
• Check analytical HPLC and mass of dissolved peptides.

Conhecimentos

Synthesis

Purification

Data analysis

Documentation

Laboratory equipment

Team collaboration

Ferramentas

HPLC

Centrifuges

Freeze dryers

Mass spectrometers

N2 tanks

Descrição da vaga

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.
  

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 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