Scientist I, Manufacturing

Job Description

Job Summary:

• You will be responsible for manufacturing products for the Bulk Formulations team and complete associated cGMP documentation.
• You will work with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD immunoassay use and participate in process improvements projects.

Duties and Responsibilities:

• Manufacture products including reagents, calibrators, buffers, controls, and intermediates, and complete batch records while maintaining cGMPs and GDP.
• Perform in-process testing using clinical analyzers and analyze raw data for in-process adjustments and product release.
• Review of other manufacturing operators/scientist’s batch records.
• Maintain and analyze lot histories for trends and discrepancies.
• Perform laboratory activities including weighing, transferring, and mixing required chemicals and performing product filtration.
• Participate in process improvement projects to improve operational efficiencies and support business needs through 5s and lab clean ups.
• Modify SOPs, work instructions, and reports with mentorship.
• Initiate and support investigations for quality documentation including non-conformances, CAPAs, and Variances.
• Maintain and troubleshoot testing and formulations equipment as appropriate.
• Keep department supervisor and/or manager updated on all issues.
• Perform other job duties as the need arises.

Education:

• BS/BA in Scientific field in Chemistry, Biochemistry, or related technical discipline; equivalent combination of education and years of related experience may be substituted.

Experience:

• 1+ years of related experience and/or training preferred.
• Laboratory skills, including pipetting, safety, and hazardous chemical handling and knowledge of safety precautions.
• Experience in working with potentially hazardous chemicals and human source materials preferred.
• Familiarity with Quality System Regulations and ISO 13485 regulations is a plus.

Knowledge, Skills, and Abilities:

• Ability to perform tasks in compliance with GMP, GDP, QSRs, ISO and IVD regulations.
• Must be organized, detail-oriented, and can prioritize own and other’s work to meet business efficiency metrics.
• Self-sufficient, self-motivated, and focused.

Physical Requirements / Work Environment:

• Controlled Substance Handling: This role involves the handling, management, and oversight of controlled substances. The role will be responsible for ensuring compliance with all relevant regulations and guidelines on controlled substances.
• Exposure to Controlled Substances: The role may be exposed to controlled substances during their duties.
• Proper safety protocols and protective measures will be provided and must be strictly followed.
• Safety Protocols: Ability to adhere to strict safety protocols and procedures to ensure a safe working environment.
• Background Check: Successful completion of a background check, including screening for any history related to controlled substances.
• Ability to occasionally lift 50lbs, routinely lift 25lbs