Analyst

• Perform GMP compliant testing as required to support Raw Material testing, In-process, Finished Product Release & Stability, nonclinical / clinical studies, as well as assay or process validations.
• Maintain laboratory documentation and perform preventative maintenance and calibration on laboratory equipment per established procedures.
• Author and ownership of investigations, deviations, critical reagent and standard qualifications, validation/verification protocols and reports, supplier qualifications, CAPAs and change controls.
• Subject matter expert in defined areas of responsibility.
• Assist supervisor in lab scheduling and planning.
• Receive test samples, standards, chemicals, and reagents; maintain accurate laboratory records and inventory for all laboratory materials.
• Demonstrate a high degree of proficiency and independence when performing analytical test methods.
• Advanced proficiency in a wide variety of analytical/biological/Compendia methodologies and techniques with a clear understanding of regulatory requirements.
• Strong background in multiple analytical techniques chemical, physical, immunological, microbiological and viral. Examples include but are not limited to: • Spectroscopy (UV, IR, Ramen, etc) • Wet lab techniques (protein concentration, Particles HIAC, Extractable volume, osmolality, etc.) • Microbial counts, endotoxin, sterility • DNA extraction, Cell Culture, qPCR, ELISA, immunoglobulin assays, etc. • Report results and complete LIMS data entry in a timely manner. Perform peer review of QC data, review, and approval in LIMS.
• Adhere to all effective STM’s/SOPs and safety requirements and document laboratory work consistent with cGMP requirements.
• Perform preventative maintenance / calibration on laboratory equipment, demonstrate advanced proficiency, and perform training in their use and maintenance in accordance with established procedures.
• Execute critical reagent and standard qualification studies and independently write protocols/reports; review and provide feedback.
• Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.
• Plan and execute experimental tasks, make detailed observations of experimental tasks and obtain and interpret experimental data with minimal guidance.
• Lead troubleshooting/laboratory investigation efforts. Identify patterns and trends, troubleshoot abnormalities, and investigate problems.
• Write clear and concise assay forms, TMDs, SOP’s, protocols, technical studies, and reports independently. Revise lab documentation including assay forms, test method documents, and standard operating procedures in accordance with document management procedures.
• Provide training and assistance to peers and junior staff in an effective manner.
• Execute development and validation studies and write protocols/reports; review and provide feedback.
• Identify opportunities for improvements within QC procedures and documentation.
• Perform tasks effectively and independently.
• Collaborate across functional areas to effectively resolve problems.
• Independently move projects forward; guide project progression through appropriate decision making.
• Other duties as assigned.

Analyst III, QC Laboratory Services

ISEMC Analyst – SOC