Support pharmaceutical development in a GxP-regulated laboratory performing analytical testing, method development, and validation.
Compensation
Compensation: $85,000-$95,000 per year
Responsibilities
Perform complex analytical testing using techniques such as HPLC, UPLC, LC-MS, GC, GC-MS, UV/Vis, FTIR, spectroscopy, dissolution, and supplementary wet chemistry in accordance with SOPs and GxP requirements.
Lead analytical method development, optimization, and validation activities to ensure methods are suitable for intended use and compliant with regulatory requirements.
Analyze and interpret data, troubleshoot analytical issues, and prepare clear summaries, technical reports, and documentation of experimental results.
Document procedures, observations, results, deviations, and investigations accurately in laboratory notebooks, LIMS, and other required systems.
Lead and facilitate OOS and OOT investigations, help identify root causes, and support corrective and preventive actions.
Requirements
Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field
Responsible for quality control activities for GMP manufacturing of cell and gene therapy products, including testing, method development, equipment qualification, and audit participation.
Responsibilities
Delivers quality control-related services including sample management, testing, method development, optimization, qualification and validation, stability program, data review and equipment management.
Collaborates with the Production, Manufacturing Science and Technology (MSAT), and Quality Assurance (QA) teams in the preparation of master batch record, sampling plans, and specifications.
Maintains the materials specification program.
Releases materials.
Manages the retain and references standard program.
Requirements
Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry etc.)
Analysis of in process, intermediate, raw material, packaging material, ETP and utility samples, stability samples, R&D samples and other samples as per plant requirement as per defined STP’s.
Calibration of all equipment in QC department as per SOP’s.
Maintain the records of calibration, working standards, stability data, AMC, outside calibration records, instrument log book, validation report, in process and intermediates test reports as per GLP.
Perform analytical method validation as and when required.
Perform analytical method development project as and when required.
Lead the development and operation of a structural mass spectrometry platform in the Zhou Lab, focusing on native, crosslinking, HDX, and intact-protein/top-down MS techniques.
Compensation
Annual salary range: $75,920 - $85,500, commensurate with qualifications and experience.
Responsibilities
Establish, optimize, and run structural-MS workflows
Develop native-MS and/or crosslinking-MS methods
Prepare and evaluate samples
Optimize ionization and fragmentation
Establish quality-control standards
Requirements
PhD in analytical chemistry, biochemistry, biophysics, structural biology, or a related discipline
Lead hands-on method development, validation, and stability studies supporting advanced drug delivery systems.
Compensation
$160,000 - $190,000 based on experience and qualifications, along with an Annual Bonus opportunity.
Responsibilities
Lead the hands-on, in-house development, feasibility, validation, and transfer of critical analytical methods and procedures supporting clinical-stage ophthalmic drug delivery platforms.
Collaborate with cross-functional teams, including formulation development, process development, regulatory affairs, and quality assurance, to ensure alignment with product development goals.
Design and execute phase-appropriate analytical development plans to deliver high-quality, compliant data from preclinical evaluation through clinical trials and final marketing approval.
Prepare, review, and approve analytical protocols, reports, and sections of regulatory submissions to ensure accuracy, completeness, and compliance.
Conduct stability studies for development and GMP batches, ensuring compliance with regulatory requirements and supporting specifications and shelf-life determinations.
Lead independent study activities in LC‑MS/MS bioanalysis, including sample preparation, analysis, data processing, and method development for drug discovery and clinical studies.
Responsibilities
Execute study activities including sample preparation, LC‑MS/MS analysis, and data processing
Support method development, qualification, and optimization
Troubleshoot technical issues and propose solutions
Analyze data and prepare summaries for senior scientists
Ensure compliance with study protocols, SOPs and regulatory requirements
Requirements
Bachelor’s in chemistry, Biochemistry or chemical/biochemical engineering
Master’s in chemistry, Biochemistry or chemical/biochemical engineering
The Research Assistant III supports Discovery Bioanalysis by performing high-throughput pharmacokinetic (Fast PK) analyses to enable rapid decision-making in drug discovery programs.
Compensation
Pay Range $28–$32/hr
Responsibilities
Conduct high-throughput bioanalytical assays to support discovery pharmacokinetic (Fast PK) studies.
Prepare biological samples using manual and automated workflows.
Operate, maintain, and troubleshoot LC-MS/MS and other analytical instrumentation.
Generate, review, and verify analytical data to ensure accuracy, quality, and timely delivery.
Assist with method development, optimization, and qualification for bioanalytical assays.
Requirements
Bachelor’s degree (BS/BA) in Chemistry or a related scientific field
Nice to have: analytical chemistry experience in industry
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