Job Description

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 Kashiv’s Quality Systems.

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

Requirements

Minimum Qualifications:

Education:

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 5 years of experience in a pharmaceutical/biotech QC laboratory.
• Alternatively, Master’s degree in above areas with 3 years of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas with a minimum of 2 years of experience.

Preferred Qualifications:

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 between Kashiv and 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
• Some travel may be required

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.