Associate Scientist III, Quality Control (2nd shift)
About The Position
This position is within the Quality Control structure, under the Quality Organization. An Associate Scientist III, Quality Control, IPC Testing performs in-process control (IPC) and release testing supporting GMP manufacture of oligonucleotide antisense strand (AS), sense strand (SS), and duplex drug substance (DS), and/or stability sample testing activities for new drug substances and drug products. This role executes analytical testing (e.g., LCMS, HPLC, UV, Karl Fischer, pH, bioburden/endotoxin) during second shift operations, ensuring timely, accurate results are delivered within sample hold times to support real-time batch disposition decisions. This is a hands-on bench role requiring close coordination with Manufacturing personnel across the shift. This position reports to QC Laboratory Management. 2nd shift work hours are 1 pm – 11:30 pm, Monday - Thursday, and includes a 10% shift differential.
Requirements
- Masters in Chemistry (or related field) with 2+ years’ relevant laboratory experience in pharmaceutical/regulated environment or Bachelors in Chemistry (or related field) with 5+ years in a GMP QC or analytical laboratory environment.
- Strong attention to detail and good documentation practices; comfort working against defined hold times and turnaround targets.
- Prior experience testing oligonucleotides, peptides, or other synthetic biomolecules.
- Hands-on experience with LCMS, AEX-HPLC, RP-HPLC/UHPLC, Karl Fischer titration, or LAL/endotoxin testing.
- Experience supporting in-process (real-time) testing in a manufacturing-adjacent QC lab.
- Fully knowledgeable of cGMP and ICH laboratory requirements and operations
- Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices
Responsibilities
- Perform IPC sample receipt, preparation, and testing per approved analytical methods and SOPs at each defined IPC sample lane (e.g., crude synthesis pool, post-purification pool, post-UF/DF intermediate, final strand/duplex release)
- Execute analytical techniques which may include LCMS, AEX and RP-HPLC purity/identity testing, UV (A260) concentration/assay, Karl Fischer water content, pH, and bacterial endotoxin (LAL) testing.
- Accurately record raw data, calculations, and results in laboratory notebooks, forms, and/or batch records in real time, in compliance with good documentation practices (GDP).
- Participate in investigations (OOS, OOT, deviations) by providing accurate data, reviewing raw data trends, and executing confirmatory/re-test work as assigned.
- Monitor and comply with sample hold times; communicate promptly with Manufacturing and QC leadership regarding any hold-time risk, atypical result, or equipment issue that could impact batch progression.
- Maintain a clean, organized, and compliant lab bench and work area in accordance with GMP, safety, and 5S expectations.
- Communicate effectively with first-shift QC/Manufacturing staff during shift handoff to ensure continuity of testing and batch status.
- Ability to work both independently and collaboratively in a dynamic environment
- Demonstrates enduring flexibility and understanding with changing
Benefits
- competitive salaries
- excellent benefit package
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
