Job Specifications
Job Title: Quality Control Analyst II/III (Biologics / Biosimilars)
Location: Piscataway, NJ (Onsite: some travel to South Plainfield)
Hours / Schedule: Monday-Friday, 8:30AM-5:00PM (with occasional early / late hours once per month during production runs)
Type: Direct Hire
Compensation: $75,000 - $82,000 (based on experience)
Overview
Join a growing biopharmaceutical company that is expanding its Quality Control operations! This is a unique opportunity to advance your career in a collaborative, cutting-edge environment where you’ll work with both late-stage clinical and commercial small molecule and biosimilar products. Candidates with GMP, regulatory knowledge, protein chemistry and analytical troubleshooting sought this role.
Level II: 6+ years (Bachelor’s) or 3-4 years (Master’s)
Level III: 10+ years (Bachelor’s) or 8+ years (Master’s)
Responsibilities
Execute analytical testing for in-process, raw material, release, and stability samples
Perform and troubleshoot methods including HPLC (Empower)
Troubleshoot SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays (although some experience in this area is desired, training be provided).
Document results in compliance with GMP, ICH, and FDA standards
Author and revise SOPs, QC methods, technical reports, and investigation summaries
Support batch release, batch record reviews, and regulatory dossier preparation
Lead and/or support laboratory investigations, deviations, OOS results, and CAPAs
Participate in Quality Events and regulatory inspections (e.g., PAI)
Collaborate with cross-functional teams to ensure laboratory readiness and continuous improvement
Requirements
Bachelors Degree in biotechnology, Biochemistry, Chemistry or related field.
Strong Quality Control experience in a pharmaceutical manufacturing environment.
Previous cGMP laboratory experience - required
3 - 10 + years of experience with a major focus on QC work.
Proficiency with HPLC and Empower required (must be on resume)
SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays a plus (training will be provided – must be willing to learn and execute these tests- an opportunity to gain experience and expand your skill set).
Expertise in small molecules and protein chemistry
Ability to troubleshoot analytical data and interpret/report results accurately
Experience supporting regulatory inspections and preparing data packages/dossiers strongly desired
Strong technical writing & documentation skills (SOPs, QC methods, reports)
Benefits
This position is a direct hire position with benefits.
Keywords: HPLC, UPLC, Empower, SDS-PAGE, CE-SDS, capillary electrophoresis, ELISA, cell-based bioassay, potency, protein chemistry, biologics QC, biosimilars, cGMP, GMP, OOS, OOT, deviations, CAPA, stability testing, raw material testing, in-process testing, batch release, data integrity, SOP writing, regulatory dossier, CMC, PAI, FDA inspection, SVP, subvisible particles, USP , LIMS, QMS
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About the Company
At Joule, we believe our world is filled with possibilities - where character, integrity, and commitment drive our purpose. For over 30 years, Joule has been a trusted partner to industry-leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent. Operating at the forefront of the life sciences arena, Joule's relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects. Joule is a System One division.
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