QC Analyst II
Amneal
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 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.
Job description
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.
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
- 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.
- 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 lift at least 25 lbs.
Requirements
- Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 5 years of experience in a pharmaceutical/biotech QC laboratory, OR Master's degree with 3 years of experience, OR PhD with a minimum of 2 years of experience
- Strong background in protein chemistry
- Demonstrated ability to collaborate across multiple departments
- Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance
- Ability to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays
- Must be able to lift at least 25 lbs
Benefits
- Health Insurance
- Insurance Benefits
- 401(k) Matching
- Short-term Incentive
- Long-term Incentive
- Restricted Stock Units
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.