You will contribute to in-process method development activities for biologics molecules using chromatographic (U/HPLC), electrophoretic and isoelectric focusing (CE-SDS/Maurice®/Lab Chip GII®) and/or ELISA type techniques.
Compensation
Annually, Bonus Payment: Twice a year
Responsibilities
Independently design, develop, qualify and report fit-for-purpose, scientifically sound and high-throughput analytical methods for in-process testing of biologics molecules under general direction.
Work closely with in-process analytical testing team within Biologics Process Development (BPD) organization for seamless method transfer and life cycle management.
Apply Analytical Quality by Design (AQbD) principles and phase-appropriate approaches for method development.
Partner with Analytical Development, Quality, Compliance, and Stability teams to support method bridging, and transfer activities.
Work with automation, digital and PAT subject matter experts to validate and integrate technologies and platforms into process analytical methods.
The Staff Scientist provides expert-level technical leadership within the laboratory as a senior scientific contributor and recognized technical authority. This role delivers oversight for nonroutine programs (analytical development, validation, transfer) and/or serves as a subject matter expert (SME) for specific analytical technologies, while maintaining an active laboratory presence.
Responsibilities
Provides technical oversight for complex, non-routine analytical testing (analytical development, validation, and transfer), method establishment, and technology-driven programs.
Serves as a senior technical authority and SME for one or more analytical technologies, platforms, or scientific disciplines.
Guides scientific decision-making to ensure appropriate experimental design, execution strategy, and data interpretation.
Reviews and/or approves technical documents including methods, protocols, reports, and quality records to ensure quality and compliance.
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.
A critical technical role within the RLT CM&C Technical Operations function leading the technical transfer, development, optimization, and validation of analytical methods to support phase 1b to phase 3 radiopharmaceutical programs.
Responsibilities
Lead the design, development, and optimization of analytical methods for radiopharmaceutical API and drug products, including small molecules, peptides, and radiolabeled compounds.
Develop and optimize chromatographic methods (HPLC, UPLC, TLC, GC) and spectroscopic methods (gamma spectroscopy, mass spectrometry, UV/Vis, NMR) as appropriate for late-phase programs.
Apply phase-appropriate development strategies aligned with ICH Q14, ICH Q2(R2), and applicable USP/EP compendial requirements.
Identify and implement analytical technology improvements and method modernization initiatives.
A critical technical role within the RLT CM&C Technical Operations function, leading the technical transfer, development, optimization, and validation of analytical methods to support phase 1b to phase 3 radiopharmaceutical programs.
Responsibilities
Lead the design, development, and optimization of analytical methods for radiopharmaceutical API and drug products
Develop and optimize chromatographic methods (HPLC, UPLC, TLC, GC) and spectroscopic methods (gamma spectroscopy, mass spectrometry, UV/Vis, NMR)
Apply phase-appropriate development strategies aligned with ICH Q14, ICH Q2(R2), and applicable USP/EP compendial requirements
Identify and implement analytical technology improvements and method modernization initiatives
Responsible for planning, executing, and documenting analytical method transfers, validations, verifications, and method improvement initiatives in compliance with regulatory requirements.
Responsibilities
Coordinate and execute analytical method transfer activities between sending and receiving laboratories
Prepare method transfer protocols and reports in accordance with internal SOPs and regulatory expectations
Provide technical training and support during method transfer execution
Investigate and troubleshoot discrepancies during or after method transfer
Develop method validation strategies aligned with ICH, FDA, EMA, USP, and other relevant regulatory guidelines
Requirements
Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline
Lead and execute drug product development activities from candidate selection through commercialization, applying biochemical, biophysical, and microbiology principles to formulate, analyze, and optimize biologic drug modalities.
Compensation
Salary Range (annually) $112,100.00 - $182,900.00
Responsibilities
Design and conduct formulation development and stability studies
Perform analytical development and microbial analysis
Develop and transfer new technologies and processes
Prepare and deliver presentations, SOPs, and patents
Maintain accurate laboratory records and comply with data integrity procedures
Requirements
Ph.D. in Pharmaceutical Science, Biochemistry, Chemistry, Microbiology, Biophysics, Engineering, or related field
BS or MS with 8-10 years of experience, or Ph.D. with 0-3 years of experience
Lead and oversee the transformation of Quality Management Systems within a complex laboratory environment, driving digital modernization, regulatory compliance, and operational excellence.
Compensation
$173,200.00 - $272,600.00
Responsibilities
Architect and modernize QMS architecture
Lead QMS integration strategy
Oversee digital quality governance
Ensure regulatory compliance and inspection readiness
Manage cross-functional QMS workstream
Requirements
Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, Engineering, Life Sciences, or related discipline
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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