Formulation Chemist/Manufacturing Operations/QA/Team Lead (GMP)
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. This position offers long-term growth potential, with opportunities to expand into broader operational responsibilities and progress into leadership or management roles for high-performing individuals. The Chemist maintains accurate batch records, ensures organization of the cold room, freezer, and formulation laboratory, and contributes to operational efficiency. This role also supports documentation activities, including writing, reviewing, revising, and updating manufacturing documents and SOPs. The ideal candidate thrives in a fast-paced, hands-on manufacturing environment, demonstrates strong multitasking abilities, and brings a proactive, solutions-oriented mindset while maintaining a safe and compliant workplace.
Requirements
- Associate degree in Chemistry, Biology, or a related field with a minimum of three (3) years of relevant laboratory or manufacturing experience in a GMP or IVD environment; OR
- Bachelor’s degree in Life Sciences, Biology, Biochemistry, or related field with a minimum of one (1) year of relevant experience; OR
- Equivalent combination of education and experience.
- Candidates must have prior hands-on work experience.
- Knowledge of solution chemistry and basic formulation principles.
- Experience in manufacturing environments with high workload demands, including physical tasks.
- Strong understanding of GMP-regulated environments, with exposure to audits, documentation review, validation protocols, and SOPs.
- Familiarity with deviation reporting, root cause analysis, and document control processes.
- Ability to follow established procedures and accurately execute formulations.
- Strong attention to detail and documentation accuracy.
- Effective communication skills and ability to collaborate cross-functionally.
- Proactive, resourceful, and hands-on mindset with a “go-getter” attitude.
- Ability to think critically, take initiative, and step up in a dynamic environment.
Nice To Haves
- Team lead or supervisory experience in a manufacturing environment.
- Combination of operational and quality experience.
- Prior experience in IVD or regulated manufacturing settings.
- Formulation experience is preferred but not required; strong manufacturing experience in large-scale environments is highly valued.
Responsibilities
- Prepare and execute bulk solution formulations in accordance with established procedures.
- Perform hands-on manufacturing activities, including handling materials and supporting production operations (lifting, pulling, and movement of materials as needed).
- 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 efforts.
- Ensure compliance with applicable GMP, ISO 13485, and internal quality system requirements.
- Contribute to a safe, positive, and collaborative work environment.
- Perform additional duties as assigned by management.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
