Job Description

We are seeking a Production Chemist to join our Manufacturing Department and be responsible for the manufacture of bulk clinical and commercial kit reagents. Advanced safety knowledge and compliance with cGMP and ISO 13485 is essential for this position. If you have the necessary skills and experience to excel in this role, we want to hear from you!

Responsibilities

As a Production Chemist, you are responsible for the subassembly formulation, raw material preparation and/or processing, QC testing reagent or component formulation and some in-process testing. You will manage the development, planning, and implementation of manufacturing methods, processes, and operations for new or existing products or technologies.

Additional Responsibilities Include

• Staging of raw materials and formulation of reagent bulks or constituents
• Maintaining detailed device history records and maintaining training log
• Ensuring proper transportation, handling, and disposal of hazardous, biohazardous and/or infectious substances
• Operating and calibrating all general lab equipment
• Completing ERP transactions
• Maintaining measures and dispensing materials and performing cycle count of materials
• Participating in PPDs and DRs investigations.
• Assisting with the execution of process validations of new and existing mfg. processes
• Assisting in the preparation of technical reports
• Reviewing and updating procedures

Qualifications

As our Production Chemist with a background in chemistry, biology and/or biochemistry, you must have the necessary education, skills and experience for this position.

Additional Requirements Include

• Bachelor’s degree in Chemistry, Biological/Life sciences, or equivalent discipline; minimum BS degree in Biological Science
• Experience in general laboratory techniques (reagent preparation and measurement)
• Experience working with automated filling equipment, a plus
• Ability to follow procedure and conduct documents following GMP/GLP
• Willingness to work with human blood and blood products
• Ability to work in a fast-paced setting, interacting with individuals from other groups
• Must have multi-tasking, organizational and good interpersonal skills, and be team-oriented

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