QC Chemist I / II in S. Plainfield, New Jersey at Prolong Pharmaceuticals LLC

Prolong Pharmaceuticals is a clinical-stage biotechnology organization advancing biologics, biosimilars, and novel PEGylated protein therapeutics for serious and life-threatening conditions. The team is science-driven and data-focused, with an emphasis on rigorous CMC development, robust analytical characterization, and high-quality clinical execution. The environment is lean and highly collaborative; team members take ownership and help build the quality systems that will support future late-stage and commercial programs.

POSITION SUMMARY:

The QC Chemist performs routine GMP analytical testing in support of clinical-stage biologics and biosimilar programs. The role executes approved test methods, keeps the laboratory and its instruments inspection-ready, and produces complete, accurate, and contemporaneous GMP records.

This is a hands-on bench role on a small team. The ideal candidate is reliable and detail-oriented and is comfortable owning day-to-day lab operations alongside testing.

Testing

• Perform routine GMP testing of raw materials, in-process samples, drug substance, drug product, and stability samples per approved test methods, specifications, and SOPs.

• Perform analyses using HPLC/UPLC (RP, SEC, IEX), CE-SDS, cIEF, and UV/Vis, as well as compendial tests such as pH, osmolality, appearance, and particulates; process and report results.

• Prepare mobile phases, buffers, reagents, and reference standard solutions, with correct labeling and expiry assignment.

• Perform stability pulls per approved protocols and complete testing within required timeframes.

• Execute method transfer and validation protocols as assigned, under the direction of the QC Supervisor or a designated Scientist.

• Identify atypical, OOS, or OOT results and escalate them immediately to the QC Supervisor.

Laboratory maintenance and operations

• Perform daily and periodic instrument checks, calibration verifications, and routine user maintenance; keep equipment logbooks current.

• Coordinate vendor visits for preventive maintenance, calibration, and repairs, and file the resulting service records.

• Receive, log, and store samples; maintain chain of custody and manage retained sample storage.

• Manage lab inventory of reagents, columns, reference standards, and consumables, including reordering and expiry tracking.

• Monitor controlled storage (refrigerators, freezers, stability chambers) and respond to excursions per SOP.

• Maintain lab housekeeping and 5S standards, manage chemical waste per procedure, and support lab safety readiness.

Documentation and compliance

• Record all work contemporaneously in laboratory notebooks, logbooks, worksheets, and chromatography data systems per GMP and ALCOA+ data integrity principles.

• Perform peer review of other analysts' data and documentation as assigned (QC Chemist II).

• Support OOS/OOT investigations, deviations, and CAPAs by providing data, records, and bench-level observations.

• Draft or revise SOPs, work instructions, and forms for lab procedures and equipment.

• Complete all assigned GMP, safety, and procedural training on time.

• Support internal audits and regulatory inspections as needed.

Education: Bachelor's degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related discipline.

QC Chemist I: 0–2 years in a pharmaceutical or biotech QC laboratory; GMP lab experience, including internships or co-ops, preferred. Hands-on HPLC experience (academic or industry) required.

QC Chemist II: 2–5 years of GMP QC testing experience, with demonstrated ability to independently execute routine methods, perform peer data review, and support investigations. Biologics or large-molecule testing experience strongly preferred.

Technical skills

• Working knowledge of GMP, Good Documentation Practices, and data integrity (ALCOA+).

• Hands-on operation of HPLC systems; familiarity with CE-SDS, cIEF, UV/Vis, and wet-chemistry techniques.

• Experience with a chromatography data system such as OpenLab CDS, Empower, or ChemStation.

• Accurate analytical technique: weighing, pipetting, volumetric preparation, and solution handling.

• Basic instrument troubleshooting and maintenance.

• Proficiency with Microsoft Word, Excel, and Outlook.

Core competencies

• Strong attention to detail and commitment to right-first-time documentation.

• Reliable, organized, and able to manage a routine testing schedule against deadlines.

• Collaborative and adaptable in a small, fast-paced team environment.

• Communicates clearly and raises issues promptly with the QC Supervisor and team.

• Follows procedures precisely and flags discrepancies between written procedures and actual practice.

• Laboratory-based role in a GMP QC environment; the majority of the workday is spent at the bench or operating instruments.

• Ability to stand for extended periods and perform repetitive hand motions (e.g., pipetting, sample preparation).

• Ability to safely handle chemicals and biological materials using appropriate PPE.

• Ability to occasionally lift up to 25 lbs (e.g., solvent containers, supply deliveries).

• Occasional early, late, or weekend coverage may be required for stability time points, equipment alarms, or time-sensitive testing.

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Prolong Pharmaceuticals, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Prolong Pharmaceuticals, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.