Quality Control Analyst

The Quality Control Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories and will also be expected to be engaged in continuous improvement initiatives to drive efficiency and effectiveness of Quality initiatives A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required. Essential Duties & Responsibilities Analytical testing to support product in-process, release, and stability programs. Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance. Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans. Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports. Train other analysts to perform laboratory procedures and assays. Participate in internal assessments and audits as and when required. Performs other functions as required or assigned Complies with all company policies and standards Position Requirements and Qualifications Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 3 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master's degree in above areas with 1 years of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas with a minimum of 2 years of experience. Experience: Previous experience in a cGMP laboratory. Strong background in protein chemistry and experience troubleshooting analytical results. Demonstrated success at writing, revising, and complying with SOPs, protocols/reports, and QC methods. Special Skills: Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. Previous experience supporting regulatory inspections (e.g. PAI). Familiarity with preparing regulatory dossiers and data packages for interactions with regulatory agencies. Work Environment & Physical Demands: Some time spent in an office doing office work (reading, writing, reviewing, and editing documents). Significant amount of time spent in the laboratory. Must be able to work extended hours or weekend hours as requested. Must be able to lift at least 25 lbs. Ability to work under pressure and meet deadlines. High-paced environment structured to meet ambitious project goals