Microbiology Technician

CSBio is a peptide contract manufacturer founded in 1993 serving research organizations and pharmaceutical companies worldwide with automated synthesizers and high quality cGMP peptides. We operate cGMP peptide production facilities in Menlo Park CA and passed an FDA inspection in 2017 that recommended us for commercial drug substance 2023 we added cGMP clinical production capacity in Milpitas CA.

Position Summary

CSBio is seeking a detail-driven Microbiology Technician to join our QC Microbiology laboratory at our Milpitas facility. You will primarily perform bacterial endotoxin and bioburden testing on peptide intermediates APIs and drug products with a focus on our GMP programs. This is an ideal role for a recent BS graduate or early-career technician looking to build a career in pharmaceutical QC microbiology; full training will be provided. Fully on-site at our Milpitas facility.

Job Responsibilities

Endotoxin testing: Perform LAL-based bacterial endotoxin testing (USP <85>) on in-process samples APIs drug products and water.

Bioburden testing: Perform microbial enumeration and tests for specified microorganisms (USP <61> / <62>) on raw materials intermediates and finished product.

Monitoring support: Assist with environmental monitoring of cleanrooms and water-system monitoring; read enumerate and record microbial growth.

cGMP documentation: Record raw data and results in worksheets and LIMS per cGMP and ALCOA data-integrity practices; support OOS/OOT investigations and deviations.

Clinical batch support: Support timely testing and release of API and clinical batch products to production timelines.

Lab operations: Prepare and quality-check media and reagents; maintain aseptic technique equipment and laboratory supplies; and perform other QC micro duties as assigned.

Why This Role

You will learn compendial endotoxin and bioburden testing end-to-end in an FDA-inspected cGMP environment working alongside an experienced Microbiology Lead on testing that directly enables clinical and commercial peptide products to reach patients.

BS degree in Microbiology Biology Biochemistry Biotechnology or a related life-science discipline. An Associate degree with relevant laboratory experience will be considered.

02 years of laboratory experience; academic internship or co-op laboratory experience qualifies for entry-level candidates.

Working knowledge of aseptic technique and basic microbiology laboratory practices.

Careful accurate documentation habits strong attention to detail and the ability to follow written procedures precisely.

Able to commit to a full-time fully on-site role at the Milpitas facility including occasional off-shift or weekend hours to meet clinical batch testing timelines.

Ability to wear sterile cleanroom gowning (including face masks gloves and safety glasses) for extended periods.

Ability to lift up to 25 lbs (e.g. media prep supplies autoclave loads).

Good manual dexterity for precise pipetting and sample handling.

Nice to haves:

Hands-on experience with bacterial endotoxin (LAL) testing and/or bioburden / microbial enumeration methods (USP <85> <61> <62>).

Exposure to a cGMP pharmaceutical biotech or other regulated laboratory environment.

Familiarity with environmental monitoring water-system monitoring or media preparation.

Experience with LIMS and electronic data-recording systems and understanding of data integrity (ALCOA) and good documentation practice (GDP).

Medical dental and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 90% for Employee and 75% for Employees 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 ($20000 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

Required Experience:

IC