Formulation Chemist I (GMP or IVD)
About The Position
Position Summary The Formulation Chemist I is responsible for preparing routine bulk solutions used in the manufacturing of in vitro diagnostic (IVD) products. This role performs formulation activities in compliance with established procedures and documentation requirements to support the production of high-quality IVD products. The Chemist maintains accurate batch records, ensures organization of the cold room, freezer, and formulation laboratory for operational efficiency, and writes, reviews, revises, and updates manufacturing documents and SOPs. This position contributes to operational excellence by identifying process efficiencies, supporting quality system requirements, and performing additional duties as assigned. The ideal candidate thrives in a fast-paced environment, demonstrates strong multitasking abilities, and maintains a positive, collaborative approach while fostering a safe and compliant work environment. Supervision Works under minimal supervision.
Requirements
- Knowledge of solution chemistry and basic formulation principles.
- Ability to follow established procedures and accurately execute bulk solution formulations.
- Experience with formulation equipment, weighing techniques, and interpretation of batch records.
- Understanding of GMP, ISO 13485, and laboratory safety practices.
- Basic knowledge of deviation reporting, document control, and root cause analysis.
- Strong attention to detail and documentation accuracy.
- Effective communication skills and ability to collaborate within cross-functional teams.
- Demonstrates initiative, accountability, and a positive attitude in a fast-paced manufacturing environment.
- Associate degree in Chemistry, Biology, or a related field with a minimum of three (3) years of formulation or laboratory experience in a GMP or IVD manufacturing environment; OR
- Bachelor’s degree in Life Sciences, Biology, Biochemistry, or related field with a minimum of one (1) year of related experience; OR
- Equivalent combination of education and experience.
Responsibilities
- Prepare and execute bulk solution formulations in accordance with established procedures.
- Assist with raw material qualification, in-process checks, and formulation-related CAPAs or nonconformances (NCs).
- Review and maintain accurate batch records and formulation documentation.
- Organize and maintain the cold room, freezer, and formulation laboratory for optimal efficiency.
- Write, review, revise, and update manufacturing documents, SOPs, and other technical documentation.
- Support departmental inventory management activities.
- Participate in process improvement initiatives and continuous quality enhancement activities.
- Maintain compliance with applicable quality system requirements.
- Contribute to a safe, positive, and collaborative work environment.
- Perform additional duties as assigned by management.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
