Senior technical leader and subject matter expert in flow cytometry for the Cell Laboratory team, providing scientific and technical guidance, training, and quality oversight in a GMP environment.
Responsibilities
Provides technical oversight for complex, non-routine analytical testing
Serves as a senior technical authority and SME for analytical technologies
Guides scientific decision-making for experimental design and data interpretation
Reviews and approves technical documents
Designs, executes, and oversees complex laboratory experiments
Requirements
Bachelor's degree or equivalent
PhD
MS degree
Nice to have: Extensive Flow Cytometry experience in a GMP environment
A senior scientific contributor providing technical leadership for complex analytical activities, method development, and validation within biopharmaceutical programs.
Responsibilities
Provide technical leadership and oversight for complex, non-routine analytical testing, including method development, validation, transfer and method establishment activities.
Serve as a subject matter expert for one or more analytical technologies, platforms, assays or scientific disciplines.
Design, execute and oversee complex laboratory experiments and analytical activities.
Guide scientific decision-making around experimental design, execution strategy, data interpretation and troubleshooting.
Maintain an active laboratory presence, providing hands-on scientific support and ensuring alignment between technical strategy and laboratory execution.
Requirements
Bachelor’s degree or equivalent relevant academic/vocational qualification
We are seeking an innovative and highly motivated Analytical Development Scientist to join our R&D organization. In this role, you will contribute to the development and commercialization of next-generation analytical technologies with a primary focus on HPLC products and processes supporting critical to quality attributes in the biotechnology and biopharmaceutical industries.
Compensation
The salary range estimated for this position based in Massachusetts is $92,000.00–$135,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
Responsibilities
Develop, optimize, and apply analytical HPLC methods to characterize product performance and support new product development.
Design and execute experiments to evaluate product attributes relevant to regulated bioprocessing, biologics development, and drug-quality monitoring.
Develop analytical strategies to assess critical-to-quality attributes, including purity, aggregation, charge variants, identity, concentration, or other relevant product and process attributes.
Generate, analyze, and interpret complex analytical datasets to guide technical decisions, product requirements, and development strategy.
Evaluate HPLC product performance across relevant use conditions, sample types, workflows, and customer applications.
Requirements
Ph.D. or M.S. with 3+ years of experience in Analytical Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related scientific field
Associate Director-Small Molecule, Analytical Development
Lead and oversee analytical development activities for small molecule drug substance and drug product programs across multiple dosage forms.
Locations (2)
Bridgewater, New Jersey, United States
New Jersey, United States
Compensation
$155,000.00-201,500.00 Annual
Responsibilities
Develop and implement analytical strategies to support product development from preclinical and clinical stages through commercialization.
Provide technical leadership for analytical method development, optimization, qualification, validation, verification, and lifecycle management in accordance with ICH, FDA, EMA, and other global regulatory expectations.
Manage external analytical laboratories, CROs, CDMOs, and testing partners to ensure timely execution of analytical development activities, method transfers, validation studies, and stability testing.
Review and approve analytical protocols, reports, method validation documents, specifications, development reports, and technology transfer packages.
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
Bachelor's with 5+ years of experience in Analytical Chemistry, Biochemistry, Chemical Engineering, Biotechnology, Pharmaceutical Sciences, or a related scientific field
Provide analytical expertise and cross-functional support for nitrosamine and mutagenic impurity assessments, including strategy development, analytical testing, and regulatory support.
Requirements
Bachelor's degree in Chemistry, Biochemistry, or related discipline
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