Formulation Chemist/Manufacturing Operations/QA/Team Lead (GMP)

• 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.

• 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.
• Formulation experience is preferred but not required; strong manufacturing experience in large-scale environments is highly valued.

• 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.

• Team lead or supervisory experience in a manufacturing environment.
• Combination of operational and quality experience.
• Prior experience in IVD or regulated manufacturing settings.

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