Quality Control Analyst III - Bioassay

Amneal

22h • Onsite

About The Position

Kashiv BioSciences, LLC is seeking an experienced Quality Control Analyst to join its Piscataway, New Jersey team. The role performs analytical testing and data verification in cGMP-compliant laboratories in support of late-stage clinical and commercial small-molecule and biosimilar products. It also tests samples for functional characterization of biologics across phases of biosimilar development, using techniques that include cell-based assays, ELISA, and SPR binding assays. A strong background in protein chemistry is important for performing and troubleshooting analytical methods.

The analyst supports in-process, release, and stability testing, and contributes to laboratory investigations, corrective and preventive actions, documentation, equipment maintenance, and cross-functional project work. The position operates in a fast-paced environment and includes significant laboratory work as well as some office-based reading, writing, reviewing, and editing of documents. Minimal travel may be required. The role may require extended or weekend hours.

The annual salary range is $93,000–$123,000. The position also offers an opportunity for a short-term incentive, such as a bonus or performance-based award, and a long-term incentive, such as restricted stock units, within the first 12 months. Eligible employees may access a flexible benefits program that includes health and insurance benefits and a significant 401(k) matching contribution.

Requirements

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field and at least 6 years of experience in a pharmaceutical or biotech QC laboratory; alternatively, a master’s degree in one of these areas and at least 4 years of such experience.
• Previous experience working in a cGMP laboratory.
• Strong background in large- and small-molecule and protein chemistry, with experience troubleshooting analytical results.
• Demonstrated ability to write and revise SOPs and comply with SOPs, policies, and QC methods.
• Demonstrated success with UV, pH meter, HPLC, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
• Strong experience with the Empower data acquisition system.
• Knowledge of cGMP, Quality Systems, and ICH and regulatory guidance.
• Ability to lift at least 25 lbs.
• Ability to work extended or weekend hours as required.

Nice To Haves

• Previous experience supporting CMC submissions.

Responsibilities

• Perform analytical testing and verify data for late-stage clinical and commercial small-molecule and biosimilar products in cGMP-compliant laboratories.
• Test samples for functional characterization of biologics across phases of biosimilar development, using techniques such as cell-based assays, ELISA, and SPR binding assays.
• Perform analytical testing supporting product in-process, release, and stability programs.
• Conduct, compile, and/or review out-of-specification laboratory investigations, deviations, and corrective and preventive action plans.
• Collaborate with cross-functional teams to advance projects, resolve laboratory investigations, and drive process improvements.
• Support equipment maintenance and author documents and reports.
• Perform raw material testing and other functions as required or assigned.
• Comply with company policies and standards.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award.
• Long-term incentive award, such as restricted stock units, within the first 12 months.
• Flexible benefits program for eligible positions.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior