Production Chemist

Job Shift: Monday-Friday, 6:30 AM-3:00 PM, Occasional overtime and weekend support may be required based on business needs

Job Description:

Summary of Duties and Responsibilities:

1. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
2. The requirements listed below are representative of basic knowledge, skills, and or abilities required.
3. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
4. Responsible for the manufacture of bulk clinical and commercial kit reagents.
5. Responsible for sub-assembly formulation.
6. Prepares and or processes raw materials.
7. Performs QC testing of reagents, component formulations and some in-process testing.
8. Participates in transfer, support activities and continuous improvement on existing processes.
9. Maintains detailed device history records and training logs.
10. Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and or infections substances.
11. Operates and calibrates all general lab equipment.
12. Completes ERP transactions.
13. Maintains measures and dispenses materials.
14. Operates CIP and or autoclave systems.
15. Fast-paced GMP manufacturing environment supporting commercial production

Must-Have Requirements:

1. Do not submit candidates missing any of the following:
2. Bachelor's degree in a Science-related field (Chemistry, Biology, Biochemistry, Microbiology, or similar)
3. Ability to work onsite and start no later than 6:30 AM
4. Ability to stand for extended periods and lift/carry up to 40 lbs.
5. Comfortable working around chemicals and manufacturing reagents
6. Willing and able to wear required PPE, including an N-95 or half-face respirator for significant portions of the workday
7. Strong attention to detail and ability to follow SOPs precisely
8. Team-oriented attitude and willingness to work collaboratively

Preferred Qualifications:

1. GMP manufacturing experience
2. Production chemistry experience
3. Reagent manufacturing experience
4. Laboratory experience
5. Experience completing batch records and controlled documentation
6. ERP transaction experience
7. Lean Manufacturing knowledge [

Key Responsibilities:

1. Manufacture bulk clinical and commercial kit reagents
2. Prepare and process raw materials
3. Perform reagent and component formulations
4. Conduct QC and in-process testing
5. Complete ERP transactions and batch documentation
6. Maintain device history records and training documentation
7. Operate laboratory equipment, autoclaves, and CIP systems
8. Support process improvements and manufacturing transfers
9. Follow GMP, quality, and safety requirements at all times