Job Description

Position Summary

• 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

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