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 complex analytical testing, method development, validation, data analysis, and technical documentation.
Compensation
Compensation: $85,000-$95,000 per year
Responsibilities
Perform complex analytical testing using HPLC, UPLC, LC-MS, GC, GC-MS, UV/Vis, FTIR, spectroscopy, dissolution, and supplementary wet chemistry
Lead analytical method development, optimization, and validation activities
Analyze and interpret data, troubleshoot analytical issues, and prepare clear summaries, technical reports, and documentation
Document procedures, observations, results, deviations, and investigations accurately in laboratory notebooks, LIMS, and other required systems
Lead and facilitate OOS and OOT investigations, 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
Nice to have: experience providing technical guidance, mentoring, training, or informal leadership
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.
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
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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