Bioanalytical Scientist

Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples. Perform data review/verification, complex troubleshooting, and method training. Own project, document revisions, deviations/investigations/CAPA, and continuous improvement efforts.

• Subject matter expert supporting method transfer/validation and routine testing of in-process, final product, and stability samples.
• Perform review of testing data (e.g., data packets, final lot file, COA review).
• Anticipate and perform complex troubleshooting and problem solving independently.
• Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products.
• Own project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts.
• May represent the department in regulatory inspections (internal and external audits).
• Train and mentor others on multiple QC test methods, processes and procedures.
• Cross trained on multiple complex analytical methods and/or multiple products.
• Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
• Perform other tasks as assigned.

• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Demonstrated technical writing skills.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Advanced ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
• Strong mentoring, coaching, influencing, negotiating and personnel interaction skills.

• Bachelor’s degree or equivalent required, preferably in science. Advanced degree preferred.
• 4 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).

• This position will report to QC management.

This position is 100% onsite.

Mon‑Fri (normal business hours).

The starting hourly compensation for this assignment is $40 – $44.63 per hour.

Equal Opportunity Employer.