Associate QC Scientist (Team Lead)

Summary:

Individual will act as team lead for QC Microbiology area. Incumbent will be mentor to junior staff and point of contact for analyst in supervisor's absence.

Front room FDA/Inspectional experience on systems, QEs, method transfers etc.

Responsibilities:

• Performs investigations for OOS, data analysis for method transfers and process investigations, assists in troubleshooting lab procedures and taking required corrective actions
• Provide the technical expertise in support of method transfer/ validation activities for the QC network or for ongoing incoming, in-process, release and stability testing.
• Ability to work across intra and inter functional departments to achieve alignment of company objectives.
• Reviews or writes technical reports and perform data analysis and trending for both method transfers and investigations.
• Recognize and troubleshooting of analytical/ microbiology method excursion. Provide guidance for equipment troubleshooting as needed.
• Trains less experienced analysts on basic and complex test methods.
• Peer review/ approval of lab data generated as a part of method transfer/ validation activities or for ongoing incoming, in-process, release and stability testing.
• Becoming proficient to write technical reports/protocols and SOPs
• Works according to cGMP requirements and HA expectations.

Qualifications:

• Knowledge of science generally attained through studies resulting in a BS/MS Degree or equiv. preferably in Biological Sciences
• Minimum of 4 years (MS)/ 6 years (BS) relevant experience in scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab.
• Proficiency (or mastery) of at least one discipline (cell based Bioassay, Immunoassay, Separation technology [chromatography], Bioburden and Endotoxin, Stability, trending, Investigation); technical knowledge/SME in a technical discipline
• A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.
• Experience in interpreting and applying cGMPs, USP, regulatory requirements and industry best practices
• Strong expertise in one or more disciplines, operational knowledge of analytical instruments to support ; familiar with method validations and procedures and method development history; proficient in lab software application such as LIMS, SmartLab, etc.
• Knowledge of US/EU Requirements and industry best practices; develops strategies for solving complex problems/issues with coaching