KB QC Analyst I
Amneal
Summary
The Quality Control Analyst I 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.
Job description
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.
- 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.
- A commitment to Kashiv's Vision, Mission, and Values is essential.
- 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 2 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master's degree in above areas with 1 year of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas.
Special Skills: Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.
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.
Requirements
- Bachelor's degree in biotechnology, biochemistry, chemistry, or related field
- Minimum of 2 years of experience in a pharmaceutical/biotech QC laboratory
- Alternatively, Master's degree with 1 year of experience in a pharmaceutical/biotech QC laboratory
- Alternatively, PhD in above areas
- Demonstrated success working with HPLC
- Demonstrated success working with SDS-PAGE
- Demonstrated success working with cell-based bioassays
- Demonstrated success working with capillary electrophoresis
- Demonstrated success working with ELISA
- Demonstrated success working with standard compendial assays
- Knowledge of cGMP
- Knowledge of Quality Systems
- Knowledge of ICH / regulatory guidance
- Ability to collaborate across multiple departments
- Ability 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
Benefits
- Health insurance
- Insurance benefits
- 401(k) matching contribution
- Short-term incentive opportunity
- Performance-based award
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.