Quality Control Analyst IV - Reviewer
hcfa.fa.us2.oraclecloud.com/KashivUSCareers · Piscataway, New Jersey, United States
The QC Analyst IV will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. 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.
- Performs other functions as required or assigned
- Complies with all company policies and standards
Minimum Qualifications
Education:
- Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 10+ years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master’s degree in above areas with 8 years of experience in a pharmaceutical/biotech QC laboratory or PhD with a minimum of 6 years of experience.
Experience:
- Previous experience in a cGMP laboratory.
- Strong background in small molecule and protein chemistry and experience troubleshooting analytical results.
- Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods.
Preferred Qualifications
Specialized Knowledge and 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.
WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:
- Typing, desk work, and plant auditing.
- Must be able to read, write, and understand English.
- Manufacturing clean rooms. Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
- Safety alertness is required due to working around hazardous equipment and conditions.
- General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines.
The salary range for this position ranges from $120,000 - $145,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.