Production Chemist (Formulation)

Location: Irvine, CA
Schedule: Monday–Friday | 7:00 AM – 3:30 PM
(4:00 PM end time if taking a 1-hour lunch)
Duration: Contract through 12/31/2026 (Potential for extension/conversion)
Pay Rate: $33.00/hour

Position Summary

We are seeking a Production Chemist to support formulation and manufacturing operations in a regulated production environment. This role is responsible for formulating biological and chemical products and intermediates while following established procedures, safety standards, and quality requirements. The ideal candidate is hands-on, detail-oriented, and comfortable working in a fast-paced laboratory/manufacturing setting with large-scale production equipment and biological materials.

Key Responsibilities

• Formulate bulk products and intermediates of low to medium complexity according to approved written procedures and specifications
• Handle biological and chemical raw materials safely and effectively in compliance with GMP, GDP, and GLP standards
• Perform data entry, material tracking, and inventory management using ERP systems (SAP experience preferred)
• Complete production batch records, equipment logs, and quality documentation accurately and in a timely manner
• Monitor manufacturing processes and make adjustments as necessary to ensure required yields and product quality
• Coordinate and prioritize daily laboratory and production tasks to meet strict production deadlines
• Follow controlled Standard Operating Procedures (SOPs) and documentation practices
• Perform setup, breakdown, cleaning, and maintenance of laboratory and production equipment
• Wash glassware, stainless steel tanks, and other laboratory equipment as required
• Support filtration and processing activities while working in cleanroom or filtration hood environments when necessary
• Work collaboratively with production and cross-functional teams to support operational goals

Work Environment & Physical Requirements

• Work with large volumes of biological materials including blood, urine, and serum (up to 3000 liters)
• Work in wet laboratory environments and temperature-controlled areas including walk-in cold rooms (2–8°C) and occasional freezer exposure
• Climb ladders to access and add raw materials into large production tanks
• Lift and handle up to 25 lbs of raw materials and supplies
• Perform pipetting, graduated cylinder measurements, and bulk material additions into production pools
• Operate and work around large-scale equipment including:
  • 3000-liter stainless steel tanks
  • Filtration presses
  • Diafiltration (TFF) systems
• Work with pressurized gas cylinders including argon and CO2
• Wear cleanroom gowning and PPE when required
• Stand for extended periods of time (4–6 hours daily)
• Work overtime as needed based on production demands

Qualifications

• Bachelor’s degree in Chemistry, Biology, Life Sciences, or a related scientific field
• 0–3 years of experience in formulation, manufacturing, laboratory production, or related environments
• Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP)
• Ability to safely handle hazardous, biological, and chemical materials
• Experience working with ERP systems; SAP experience strongly preferred
• Proficiency with Microsoft Office applications including Excel and Word
• Strong attention to detail, documentation, and organizational skills
• Ability to follow detailed procedures and work effectively both independently and within a team environment

Additional Requirements

• Must provide and wear OSHA-approved laboratory safety shoes
  • Shoes must be fully enclosed (no open backs or exposed areas)
• Must be comfortable working in laboratory and manufacturing environments with biological and chemical materials