The Manager, Finished Product & Stability Quality Control is responsible for leading all analytical testing, stability program execution, laboratory compliance activities, investigations, and personnel management associated with Finished Product and Stability testing.
Locations (2)
Central Islip, New York, United States
Hauppauge, New York, United States
Compensation
$103,000 - $136,000
Responsibilities
Manage Finished Product and Stability testing activities to support commercial product release and ongoing stability programs.
Oversee testing and review of assay, related substances, chromatographic purity, degradation products, dissolution, content uniformity, residual solvents, and other compendial requirements.
Ensure timely execution of stability sample pulls, testing, data review, trending, and reporting activities.
Lead laboratory investigations including OOS, OOT, deviations, atypical results, and CAPA implementation.
Review and approve analytical data, laboratory records, chromatograms, and technical reports.
Requirements
Bachelor's or Master's Degree in Chemistry, Pharmaceutical Sciences, or related scientific discipline
Support all stages of clinical and commercial drug product development by applying biochemical and biophysical methods to evaluate the stability and compatibility of diverse therapeutic modalities.
Compensation
Salary Range (annually)
$71,700.00 - $112,300.00
Responsibilities
Execute IV compatibility/in-use stability studies to support first-in-human (FIH), clinical, and commercial drug product dosing for various therapeutic modalities such as monoclonal antibodies, bispecific antibodies, proteins, ADCs, and AAVs
Support research and technical development in compatibility/in-use stability
Perform routine sample analysis to support formulation and product development activities
Maintain materials, equipment, and laboratory space for the compatibility/in-use stability team
Design and execute compatibility/in-use stability studies and other experiments to support testing of therapeutic protein molecules
Requirements
B.S. or M.S. in Chemistry, Biochemistry, Biophysics, Pharmaceutical Sciences, or a related field
Nice to have: Protein chemistry
Nice to have: IV admixture compatibility/in-use stability
Senior Analyst, Quality Control Chemistry responsible for reviewing, approving, and releasing QC analyses, ensuring regulatory compliance, data integrity, and timely delivery of analytical results.
Responsibilities
Review, approve and release QC analyses of finished products, raw materials, water and other materials
Lead the cell of conference and release of analytical results and analytical scheduling
Conduct investigations of out-of-specification results, deviations and related quality events
Operate and review data in systems such as Empower, LIMS and other platforms
Ensure traceability and integrity of laboratory-generated data
Requirements
Formação superior completa em Farmácia, Química ou Engenharia Química
Responsible for laboratory equipment lifecycle management and CSV support at the Biotherapeutics Manufacturing facility.
Compensation
PR: $62.51
Responsibilities
Participate in the qualification of analytical equipment for related testing functions, for example, IQ/OQ/PQ of HPLC, Spectrophotometry, Endotoxin, Cell Culture and Total Organic Carbon equipment.
Author SOP’s, Work Instructions and protocols.
Responsible for the quality control laboratory equipment lifecycle management and CSV support.
Participate in activities to introduce technologies and computer base applications to a new site, for example eLIMS/iLABS, SDMS, Empower and SoftMax Pro, SAP, to improve laboratory efficiency and promote a culture of Innovation.
Interact with the QC Global organization for the different center of excellence for equipment and information technologies.
Requirements
Bachelor’s Degree in Chemistry, Biochemistry, Micro or science related field
The Analytical Instrument Service Engineer supports a diverse range of laboratory environments by providing expertise in the installation, maintenance, and repair of advanced scientific instruments (including high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass-spectrometry systems).
Responsibilities
Develop and maintain up-to-date technical skills and expertise in the installation, maintenance, calibration, and repair of analytical lab instrumentation such as high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass-spectrometry systems.
Diagnose and resolve instrumentation performance issues via troubleshooting, repairs, and preventive maintenance.
Coordinate problem resolution with cross functional groups and external suppliers to expedite services and repairs.
Advise customers on preventive maintenance and system configurations to improve performance and minimize downtime.
Review technical documentation, analyze reports, and recommend corrective actions as needed.
Requirements
Bachelor’s degree or higher in a science-related field (e.g., Chemistry, Analytical Chemistry, Biochemistry, Biotechnology, Engineering, Biology)
Associates degree or high school diploma/GED with 5+ years of directly relevant experience
Nice to have: Experience calibrating lab equipment such as an HPLCs, GCs, and Mass Spectrometers using NIST traceable standards
Nice to have: Experience using chromatography software such as Empower
QC Lab Services Analyst (Analytical Instrument and Lab Systems) responsible for laboratory equipment lifecycle management and CSV support at a Biotherapeutics Manufacturing facility.
Responsibilities
Participate in the qualification of analytical equipment for related testing functions, for example, IQ/OQ/PQ of HPLC, Spectrophotometry, Endotoxin, Cell Culture and Total Organic Carbon equipment.
Author SOP’s, Work Instructions and protocols.
Responsible for the quality control laboratory equipment lifecycle management and CSV support.
Participate in activities to introduce technologies and computer base applications to a new site, for example eLIMS/iLABS, SDMS, Empower and SoftMax Pro, SAP, to improve laboratory efficiency and promote a culture of Innovation.
Interact with the QC Global organization for the different center of excellence for equipment and information technologies.
Requirements
Bachelor’s Degree in Chemistry, Biochemistry, Micro or science related field
Analista de Laboratorio en el área de I+D en la planta de Azuqueca de Henares, responsable de realizar y notificar ensayos analíticos, validar parámetros, elaborar informes y mantener equipos de I+D.
Compensation
Atractivo paquete salarial (salario fijo + plus rotación)
Responsibilities
Realizar y notificar ensayos analíticos para desarrollar, verificar y validar parámetros analíticos
Elaborar informes con los resultados y proponer cambios en los ensayos
Calibrar y mantener equipos de I+D y asegurar condiciones aprobadas en planta
Asesorar, formar y apoyar a otros analistas para asegurar el correcto funcionamiento de los proyectos
Requirements
Grado Superior en Análisis y Control de Calidad o similar
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