Production Chemist I (Formulation)
Production Chemist (Formulation)Location: Irvine, CASchedule: 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/hourPosition SummaryWe 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 ResponsibilitiesFormulate bulk products and intermediates of low to medium complexity according to approved written procedures and specificationsHandle biological and chemical raw materials safely and effectively in compliance with GMP, GDP, and GLP standardsPerform 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 mannerMonitor manufacturing processes and make adjustments as necessary to ensure required yields and product qualityCoordinate and prioritize daily laboratory and production tasks to meet strict production deadlinesFollow controlled Standard Operating Procedures (SOPs) and documentation practicesPerform setup, breakdown, cleaning, and maintenance of laboratory and production equipmentWash glassware, stainless steel tanks, and other laboratory equipment as requiredSupport filtration and processing activities while working in cleanroom or filtration hood environments when necessaryWork collaboratively with production and cross-functional teams to support operational goalsWork 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 exposureClimb ladders to access and add raw materials into large production tanksLift and handle up to 25 lbs of raw materials and suppliesPerform pipetting, graduated cylinder measurements, and bulk material additions into production poolsOperate and work around large-scale equipment including: 3000-liter stainless steel tanksFiltration pressesDiafiltration (TFF) systemsWork with pressurized gas cylinders including argon and CO2Wear cleanroom gowning and PPE when requiredStand for extended periods of time (4-6+ hours daily)Work overtime as needed based on production demandsQualifications Bachelor's degree in Chemistry, Biology, Life Sciences, or a related scientific field0-3 years of experience in formulation, manufacturing, laboratory production, or related environmentsUnderstanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP)Ability to safely handle hazardous, biological, and chemical materialsExperience working with ERP systems; SAP experience strongly preferredProficiency with Microsoft Office applications including Excel and WordStrong attention to detail, documentation, and organizational skillsAbility to follow detailed procedures and work effectively both independently and within a team environmentAdditional 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