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Invagen Pharmaceuticals, Inc. seeks Chemists/ Scientists / Associates/ Engineer for its Hauppauge, NY location:

Immediate Hiring

Invagen seeks full-time Quality Assurance Chemists for its Hauppauge, NY location. Bachelor’s degree or equivalent in Pharmacy or related field required. Mail resume to HR Manager, Ref: QAC, Invagen Pharmaceuticals, Inc., 7 Oser Avenue, Hauppauge, NY 11788.

1. Formulation Chemists

2. Quality Assurance Scientists

3. Quality Assurance Associate

4. Research Chemists/Scientists

5. Regulatory Affairs Associate

6. Director of Quality Assurance

7. Analytical Chemist : sought for Hauppauge, NY area to develop, validate and facilitate inter-laboratory transfer of analytical methods for active pharmaceutical ingredients and dosage forms; perform quality control activities; review and apply laboratory SOPs; Evaluate working and reference standards for pharmacopial and non-pharmacopial products; design, evaluate and monitor stability programs for drug products; test drug substances, intermediates and raw materials while conducting impurity profiles for drug substances and intermediates; work with advanced analytical equipment like HPLC, GC, DSC, IR etc. while applying knowledge of broad variety of analytical techniques, draft ANDA submissions to the US FDA etc. Bachelor’s degree or foreign equivalent in Chemistry/ Chemical Engineering/ Pharmacy or related field and 2 years relevant work experience OR in the alternative Master’s degree or foreign equivalent in Chemistry/ Chemical Engineering/ Pharmacy or related field is required.(Ref: AC)

8. Analytical Scientist : Research and develop analytical methods and perform quality control testing activities; execute method validation and stability tests; execute laboratory experiments to support R & D activities; draft and fully implement laboratory SOPs; design, evaluate and monitor stability programs; prevent and minimize errors while executing laboratory tests; conduct troubleshooting processes and laboratory investigations and prepare detailed reports; analyze and implement ICH guidelines and FDA regulations; draft and prepare submissions & responses to FDA; assist in regulatory compliance audits; perform monthly calibrations of advanced analytical equipment and apply knowledge of broad variety of analytical techniques. Master’s degree or foreign equivalent in Pharmaceutical Sciences/ Chemistry or related field required. (Ref: AS)

9. Research Associate : Invagen seeks Research Associate for its Hauppauge, NY location to analyze, research and validate chemical and physical properties of organic & 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; assists 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/ Chemistry or related field and 6 months relevant work experience required. (Ref: RA)

10. Senior Analytical Scientist : Invagen seeks Senior Analytical Scientists for its Hauppauge, NY location to develop, improve and validate analytical methods periodically; responsible for analytical method development and quality control activities; develop, review and implement laboratory SOPs; design, evaluate and monitor stability programs; evaluate working and reference standards; analyze and implement ICH guidelines and FDA regulations; draft and review submissions/responses to FDA; supervise and train scientists, chemists and technicians; monitor monthly calibrations of advanced analytical equipment; apply knowledge of broad variety of analytical techniques etc. Bachelor’s degree or foreign equivalent in Pharmacy/ Chemistry or related field and five years relevant work experience required. Multiple Positions open. (Ref: Sr. AS)

11. Facility Engineer :Design/update operating and maintenance processes/solutions for manufacturing, warehousing and engineering equipment; plan, execute and monitor internal engineering projects; prepare layout drawings for equipment & machinery; troubleshoot manufacturing/engineering equipment to develop/implement preventive maintenance solutions; prepare IQ, OQ & PQ protocols/reports for new equipment as per cGMP requirements; prepare SOPs; design/update process changes and facility plans according to FDA guidelines and OSHA specifications; train personnel on processes and use of equipment etc. Master’s degree or foreign equivalent in Mechanical Engineering or related field required. (Ref: FE)

12. Business/Management Analyst : Will develop/implement business systems & policies, develop/maintain warehouse & supply chain inventory management systems and quality management systems etc. Bachelor’s degree or equivalent required. Mail resume to HR Manager, Invagen Pharmaceuticals, Inc., 7 Oser Avenue, Hauppauge, NY 11788.

13. Logistics Analyst : Will assist in managing & coordinating logistics & purchase functions, diagnose logistics problems and develop solutions etc. Bachelor’s degree or equivalent required. Mail resume to HR Manager, Invagen Pharmaceuticals, Inc., 7 Oser Avenue, Hauppauge, NY 11788.

14. Manufacturing Chemist : Invagen Pharmaceuticals, Inc. seeks Manufacturing Chemist for its Hauppauge, NY location. Bachelor’s degree in Pharmacy/ Chemistry or related field required. Mail resume to HR Manager, Ref: MC, Invagen Pharmaceuticals, Inc., 7 Oser Ave., Hauppauge, NY 11788.

15. Medical Scientist : Invagen seeks Medical Scientist at its Hauppauge, NY location to provide medical & clinical guidance to scientists/ managers throughout & following bioequivalence clinical trials; ensure that all clinical and postmarketing adverse event filings to regulatory authorities are consistent with internal policies and applicable regulatory requirements; handle medical literature matters with FDA for ANDA filings and approved products; serve in cross-functional teams as a medical and scientific representative; draft safety narratives for initial and follow-up case processing; prepare and submit periodic reports, ICSR and generate basic PSURs to the FDA; perform MedDRA coding in accordance with guidelines/ industry standards; develop and implement SOPs for initial and follow-up case processing; ensure regulatory compliance and safety throughout trials; remediate any pharmacovigilance deficiencies found during internal/regulatory audits; establish and maintain consistency of safety assessments within the US and abroad; address labeling concerns and updates etc. Doctor of Medicine degree or foreign equivalent degree required. Must be board certified or board certification eligible.Mail resume to HR Manager, Ref: MD, Invagen Pharmaceuticals, Inc., 7 Oser Avenue, Hauppauge, NY 11788.

16. Manufacturing Scientist : Invagen seeks Manufacturing Scientist for its Hauppauge, NY location 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; draft submissions to regulatory agencies etc. Master’s degree or foreign equivalent in Pharmacy/ Pharma Technology or related field and 3 years relevant work experience required. (Ref: MS)

17. Supply Chain Specialist : Invagen seeks Supply Chain Specialist for its Hauppauge, NY location to manage/coordinate supply chain/ logistics & purchasing functions; provide expertise and develop strategies to improve logistics performance; develop & implement policies and procedures for continuous acquisitions, delivery improvement & productivity; analyze and compute large tracts of data/ records to ensure smooth logistics; warehouse operations; develop analytical/ quantitative methods to understand, predict and improve supply chain and logistics processes; develop/ maintain accurate forecasts to procure materials; identify supply chain bottlenecks by performing troubleshooting functions on a daily basis and develop solutions; ensure implementation of systems & procedures for integration of supply chain functions in compliance of CFR/ GMP guidelines, train logistics personnel etc. Master’s degree or foreign equivalent in MBA/ Supply Chain/ Logistics or related field required. Master’s degree-level coursework in supply chain/ logistics related fields required. (Ref: SCSp)

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

19. Senior Quality Control Scientist : Invagen seeks Senior Quality Control Scientist for its Hauppauge, NY location 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 Chemistry/ Pharmacy or related field and five years relevant work experience required. (Ref: SrQCS)

20. Quality Control Chemist : Invagen seeks Quality Control Chemist for its Hauppauge, NY location to Perform pharmaceutical laboratory quality control/development activities; develop and validate analytical methods; analyze raw materials and in-process/finished product samples using modern quality control techniques like HPLC, GC, XRD, UV-Vis, ICP etc.; assist in developing/implementing & maintaining QC systems & activities; work with advanced analytical equipment/ instrumentation in the laboratory; validate & analyze results as per USP, BP, EP, ICH and USFDA guidelines; perform in-process inspections & document results; update pharma lab equipment/instrumentation inspection procedures & checklists as necessary etc. Bachelor’s degree or foreign equivalent in Pharmacy/ Chemistry or related field and 2 years relevant work experience OR in the alternative Master’s degree or foreign equivalent in Pharmacy/ Chemistry or related field required. Multiple positions open. (REF: QCC)

21. Quality Assurance Chemist : Invagen seeks Quality Assurance Chemist for its Hauppauge, NY location to analyze raw materials, in-process/ finished product samples, process validation samples, water samples etc.; conduct internal audits for compliance with SOP, cGMP & FDA requirements; perform wide variety of laboratory inspections, checks, tests and sampling procedures for the manufacturing process; analyze departures from established procedures & investigate product failures; prepare and issue batch manufacturing and packaging records; prepare & implement SOPs; train personnel on SOPs; monitor critical equipment & instrumentation; work with advanced laboratory equipment etc. Bachelor’s degree or foreign equivalent in Pharmacy/ Chemistry or related field and 2 years relevant work experience required.(Ref: QAC)

22. Quality Control Scientist : Sought for Hauppauge, NY location to perform pharmaceutical laboratory quality control/ development activities; develop and validate analytical methods; analyze raw materials and in-process/ finished product samples using modern quality control techniques like HPLC, GC, XRD, UV-Vis, ICP etc.; develop/ implement & maintain QC systems & activities; work with advanced analytical equipment/ instrumentation in the laboratory; validate and analyze results as per USP, BP, EP, ICH and USFDA guidelines; perform in-process inspections; develop and fully implement SOPs; analyze scientific data and prepare detailed QC reports; draft and prepare submissions & responses to FDA; update pharma lab equipment/ instrumentation inspection procedures & checklists as necessary etc. Master’s degree or foreign equivalent in Pharmacy/ Chemistry or related field required. Multiple positions open. (Ref: QCS)

23. Associate Director – Supply Chain : Invagen seeks Associate Director – Supply Chain to plan and manage materials procurement based on business forecasts; direct and manage domestic & international logistics activities; perform budgeting and capacity planning; manage supply chain related production planning & order execution activities; manage customs agent activities such as shipment tracking/ clearance; lead inventory management activities and manage periodic stock audits; implement cGMP & FDA guidelines and compliance; manage logistics/ supply chain & warehouse personnel and lead their training activities; manage vendor network development; manage ERP implementation and upgrades etc. Bachelor’s degree or foreign equivalent in Business Management/ Administration or related field and 5 years relevant work experience required. The required 5 years work experience must be in the pharmaceutical industry and must include experience in SAP inventory management software.(Ref: SCDir)

Mail resumes to:

HR Manager

Invagen Pharmaceuticals, Inc.

7 Oser Avenue, Hauppauge

NY, 11788

 

 

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