Support MHRA Laboratories with high-quality physico-chemical testing, including analysis of reference substances, APIs, medicines, herbal products, and packaging materials.
Responsibilities
Analyse diverse samples using HPLC, GC, GC/LC-MS, Mid-IR, Raman, UV spectroscopy, dissolution, wet chemistry
Draft analytical reports, methods, and safety assessments
Run, interpret, and validate analytical data
Maintain ISO/IEC 17025-accredited quality system
Perform routine maintenance, calibration, and daily performance checks on laboratory equipment
Provide analytical support to the client’s drug substance manufacturing and method development services, involving project analysis, method development, forced degradation studies and proof of concept method validation.
Responsibilities
Provide analytical support for Eurofins’ drug substance manufacturing and method development projects
Perform project analysis, method development activities, forced degradation studies, proof of concept validation work, and data interpretation
Contribute to the authoring and review of key analytical documentation
Work independently and collaboratively within a multidisciplinary team
Apply strong technical expertise and problem-solving skills to investigate challenges
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
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