Senior Scientist, Quality Control Analytical
ImmunityBio, Inc.
5 months ago
On-site
Dunkirk, NY
Operations
Position: Senior Scientist, Quality Control Analytical
Responsibilities:
- Provide analytical testing leadership for fusion proteins, cell therapies, and cancer vaccines (wet chemistry, HPLC, capillary electrophoresis, UV-Vis spectroscopy, ELISA).
- Support In-Process testing and suitability for use testing; lead method development, optimization, transfer, qualification, and investigational studies.
- Develop and validate GMP-friendly analytical methods; draft/review validation protocols, reports, and methods.
- Troubleshoot complex analytical methods; develop new assays for release and stability (raw material, in-process, drug substance/product).
- Act as QC analytical SME (incl. identifying/purifying/separating components in unknown mixtures).
- Perform/lead structural analytical characterization of drug products and impurities (including reviewing outsource reports).
- Lead analytical investigations for non-conformance/safety issues (Root Cause Analysis), drive variability reduction and improved validation.
- Draft/edit SOPs and test plans; lead continuous improvement; track/trend KPIs and escalate adverse testing events.
- Partner cross-functionally (AD/PD, Facilities, Engineering, QA, Regulatory); perform ad-hoc cross-functional projects.
Qualifications:
- Master’s in Analytical Science with 7+ years biotech experience OR Ph.D. with 3+ years biotech experience.
- Extensive assay development, qualification, validation, and transfer experience.
- cGMP lab experience.
- Hands-on HPLC and ELISA required; biological assays (e.g., cell cultures) preferred.
Skills/Abilities (required):
- Knowledge of QC testing, equipment, cGMP/FDA/USP, basic statistics.
- Strong technical problem-solving, scientific judgment, organization, prioritization, attention to detail.
- Strong communication across teams and external entities; Microsoft Office.
- Proficiency across multiple HPLC platforms (e.g., Thermo, Agilent).
Benefits/Pay & Application:
- Discretionary bonus and equity; base pay range: $125,000–$137,500 annually.
- Application window: close in 60 days from posting (or sooner if filled/closed).
Responsibilities:
- Provide analytical testing leadership for fusion proteins, cell therapies, and cancer vaccines (wet chemistry, HPLC, capillary electrophoresis, UV-Vis spectroscopy, ELISA).
- Support In-Process testing and suitability for use testing; lead method development, optimization, transfer, qualification, and investigational studies.
- Develop and validate GMP-friendly analytical methods; draft/review validation protocols, reports, and methods.
- Troubleshoot complex analytical methods; develop new assays for release and stability (raw material, in-process, drug substance/product).
- Act as QC analytical SME (incl. identifying/purifying/separating components in unknown mixtures).
- Perform/lead structural analytical characterization of drug products and impurities (including reviewing outsource reports).
- Lead analytical investigations for non-conformance/safety issues (Root Cause Analysis), drive variability reduction and improved validation.
- Draft/edit SOPs and test plans; lead continuous improvement; track/trend KPIs and escalate adverse testing events.
- Partner cross-functionally (AD/PD, Facilities, Engineering, QA, Regulatory); perform ad-hoc cross-functional projects.
Qualifications:
- Master’s in Analytical Science with 7+ years biotech experience OR Ph.D. with 3+ years biotech experience.
- Extensive assay development, qualification, validation, and transfer experience.
- cGMP lab experience.
- Hands-on HPLC and ELISA required; biological assays (e.g., cell cultures) preferred.
Skills/Abilities (required):
- Knowledge of QC testing, equipment, cGMP/FDA/USP, basic statistics.
- Strong technical problem-solving, scientific judgment, organization, prioritization, attention to detail.
- Strong communication across teams and external entities; Microsoft Office.
- Proficiency across multiple HPLC platforms (e.g., Thermo, Agilent).
Benefits/Pay & Application:
- Discretionary bonus and equity; base pay range: $125,000–$137,500 annually.
- Application window: close in 60 days from posting (or sooner if filled/closed).