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Ascent seeks Formulation Scientist in Central Islip, NY to research, develop and design drug formulations; develop experimental prototype formulations; work with advanced in-process equipment; develop/implement methods for making products at the required scale; implement formulation protocols, process controls & test procedures to assess production process; write process validation protocols & SOPs; evaluate literature/patents and develop non-infringing formulations; train chemists and laboratory technicians etc. Master’s degree or foreign equivalent in Pharmacy/ Chemistry or related and 3 years relevant work experience required. (Ref: FS)

Ascent seeks Quality Control Scientist in Central Islip, NY to perform pharmaceutical laboratory quality control/development activities; develop and validate analytical methods; analyze raw materials and in-process/finished product samples using modern QC techniques; develop/implement & maintain QC systems & activities using advanced analytical lab equipment/ instrumentation; validate & analyze results as per USP, BP, EP, ICH and USFDA guidelines; perform in-process inspections; prepare/implement SOPs; train chemists/technicians; analyze scientific data and prepare detailed QC reports; research, draft and prepare submissions & responses to FDA; update pharma lab equipment/ instrumentation inspection procedures & checklists as necessary etc. Bachelor’s degree or foreign equivalent in Pharmacy/ Chemistry or related and 5 years relevant work experience required. Multiple positions open. (Ref: QCS)

Ascent seeks Senior Quality Control Scientist in Central Islip, NY to perform method validation activities for new ANDA batch executions and Technical Transfers; implement quality systems in laboratory and manufacturing facilities as per cGMP and GLP requirements; conduct stability sample loading/ testing of drug products as per regulatory requirements; prepare and execute stability protocols; prepare method validation reports for ANDA submissions to USFDA; troubleshoot issues during analytical method validations and while performing quality control activities; supervise and train scientists, chemists and technicians; assist in release activities for in-process & finished drug/pharmaceutical products etc. Bachelor’s degree or foreign equivalent in Pharmacy/ Chemistry or related and 5 years relevant work experience required. Multiple positions open. (Ref: SrQCS)

Ascent seeks Research Associate in Central Islip, NY to analyze, research and validate chemical and physical properties of organic and inorganic substances; test and validate drug products; analyze raw materials and finished products; provide quality improvements and standardization; perform batch level quality control and in-process inspections of drug products and packages; assist in designing and improving methods of investigation to reduce defects; implement SOPs and prepare reports on content absorption, dissolution, disintegration, weight variations etc. among others. Bachelor’s degree or foreign equivalent in Pharmacy/ Microbiology/ Chemistry or related and 2 years relevant work experience required. (Ref: RA)

Ascent seeks Manufacturing Scientist in Central Islip, NY to plan & coordinate activities related to manufacturing of various dosage forms; develop pharmaceutical dosage forms using advanced scientific techniques; develop new process concepts for product optimization and yield improvement; implement monthly production plans & generate monthly reports; perform IQ, OP & PQ of production equipment; work with product development team to execute bio-batches & validation batches; develop SOPs; supervise & train chemists and technicians; draft submissions to regulatory agencies etc. Master’s degree or foreign equivalent in Pharmacy/ Pharma Technology or related and 3 years relevant work experience required. (Ref: MS)

Ascent seeks Senior Analytical Scientist in Central Islip, NY to develop, improve and validate analytical methods periodically; responsible for analytical method development and QC activities; develop, review & implement laboratory SOPs; design, evaluate and monitor stability programs; evaluate working/ reference standards; analyze and implement ICH guidelines and FDA regulations; draft and review submissions to FDA; supervise and train scientists, chemists & technicians; monitor monthly calibrations of advanced analytical equipment; apply knowledge of broad variety of analytical techniques etc. Bachelor’s degree or foreign equivalent in Chemistry / Pharmacy or related and 5 years relevant work experience required. (Ref: SrAS)

Ascent seeks Senior Quality Assurance Scientist in Central Islip, NY to implement and maintain quality system & procedures in pharmaceutical laboratories & facilities; audit & inspect QC & analytical development activities; ensure compliance with all applicable regulations & internal standards; provide regulatory & technical expertise with respect to laboratory quality systems; supervise & train scientists, chemists & technicians; review & approve cGMP related policies and SOPs; design/conduct internal audits & inspections to meet FDA requirements; provide support for new ANDA submissions; participate in regulatory audits & inspections etc. Bachelor’s degree or foreign equivalent in Chemistry / Pharmacy or related and 5 years relevant work experience required. (Ref: SrQAS)

Ascent seeks Analytical Manager for our Central Islip, NY location to develop analytical method validation techniques for various raw materials; design, evaluate and monitor stability programs for drug products; assist senior management in planning/managing analytical R & D activities and provide technical expertise to senior management; coordinate and manage all aspects of analytical development and stability activities; ensure compliance with cGMP guidelines and FDA regulations; supervise and train scientists, chemists and technicians; work with advanced analytical equipment; apply knowledge of broad variety of analytical techniques; prepare/review SOPs and ANDA submissions etc. Bachelor’s degree or foreign equivalent in Pharmacy/ Chemistry or related field and five years relevant work experience required. Mail resume to HR Manager, Ref: AM, Ascent Pharmaceuticals Inc., 400 S. Technology Drive, Central Islip, NY 11722.

Ascent seeks Analytical Scientist for our Central Islip, NY location to develop, validate and conduct inter laboratory transfer of analytical methods for active pharmaceutical ingredients (API) and dosage forms; validate analytical methods and perform quality control activities; research & develop efficient and selective analytical procedures and draft/review laboratory SOPs; design, evaluate and monitor stability programs for drug products; work with advanced analytical equipment; supervise and train chemists and laboratory personnel; test drug substances, intermediates and raw materials while conducting impurity profiles for drug substances and intermediates; prepare ANDAs for FDA submissions etc. Bachelor’s degree or foreign equivalent in Pharmacy/ Chemistry or related field and five years relevant work experience required. Mail resume to HR Manager, Ref: AS, Ascent Pharmaceuticals Inc., 400 S. Technology Drive, Central Islip, NY 11722.

Ascent seeks Quality Control Chemist in Central Islip, NY to scientifically analyze and test raw materials, in-process and finished product samples using modern quality control techniques; develop, validate and test analytical methods for analytical pharmaceutical ingredients (API) and dosage forms; perform quality control/development activities using Chromatography, Spectroscopy, HPLC, GC, TLC, Dissolution etc.; work with advanced analytical equipment like HPLC, GC, DSC and IR and apply knowledge of broad variety of quality control and analytical techniques; validate and analyze results as per regulatory standards such as USP, BP, EP, ICH and USFDA; develop, implement and maintain QC systems and activities; perform in-process inspection, document results and perform a wide variety of inspections, checks, tests and sampling procedures for the manufacturing process; calibrate/check critical laboratory equipment and instrumentation; draft laboratory SOPs, inspection procedures & checklists; assist in preparing ANDA submissions etc. among others. Bachelor’s degree or foreign equivalent in Pharmacy/Chemistry or related field and 3 years relevant work experience or in the alternative Master’s degree or foreign equivalent in Pharmacy/Chemistry or related field and 1 year relevant work experience required. Multiple positions open. Mail resume to HR Manager, Ref: QCC, Ascent Pharmaceuticals, Inc., 400 S. Technology Dr., Central Islip, NY 11722.