Amneal employees around the world understand that every product we develop, manufacture and distribute is destined for someone’s loved one. It is this shared belief that drives our commitment to provide greater access to high-quality, affordable medicines and the meaningful role they play in treatment and care for patients globally.
Post : Scientist II
Job Description:
Scientist 2 will support the team of scientists and contribute towards the development of the drug products intended for regulatory registration. The primary responsibilities include the development of product and process and create the documents for ANDA submission. The Scientist-II will take a lead in the developmental activities at the bench level and maintain cGMP compliance. The position reports to a Manager/ Group Leader/ Principle Scientist as described in the current organization chart of the department.
Essential Functions:
• Primary focus on aerosol testing using standard HPLC analysis as well as advanced analytical testing required for inhalation products.
• Support DPI and MDI formulation and process through data generation with in Amneal laboratories. Position requires analytical method development and validation.
• Engage in formulation analysis and conduct product characterization studies and analytical aerosol testing.
• Effective contributor based upon management direction. Compile results from all development studies in scientific reports.
• Support the maintenance of a safe and compliant work place.
Additional Responsibilities:
• Assist, as and when needed, senior scientists working in the laboratory.
• Ensure that expired chemicals and reference standards are removed from laboratory area, perfrom calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, GC as assigned by the supervisor.
• Standardize API for use as in-house reference standard as assigned.
• Interact with newly hired laboratory technicians or Assistant Scientists for providing hands-on training on simple analytical techniques and laboratory instruments.
Candidate Profile
• Bachelors Degree (BA/BS) Chemistry or related science discipline with 3-5 years exp or Required
• Master Degree (MS/MA) with 1-2 year chemistry or related technical field - Preferred
• Testing of pharmaceutical products
Skills:
• Must be precise and consistent in day to day analysis, using sophisticated analytical instruments. - Advanced
• Must be familiar with out of specification and out of alert limit investigations. - Intermediate
• Must be able to execute compendial procedures involving complexity. - Intermediate
• Must be familiar with cGMP and OSHA regulations. - Intermediate
• Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate
• Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate
• Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Intermediate
• Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Intermediate
• Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Intermediate
• Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate
• Must be able to assume a role of a leader in team environment as and when required. - Beginner
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Specialized Knowledge:
• Significant experience in inhalation products analytical testing (such as (ACI, NGI, Light Scattering, DCU, Spray Pattern, Plume Geometry, Leachable and Extractables) is required.
• Strong knowledge of formulation and manufacturing sciences (product development, process research, scale-up and technology transfer) in Inhalation (single dose blister DPIs and MDIs, dose counters and human factor assessments acquired through academic training plus on-the-job experience.
• Experience in DPI blister formulation, manufacturing and testing will be preferred.
• Inhalation product manufacturing experience will be an advantage
Additional Information
Experience : 1-5 years
Qualification : B.Sc, M.Sc
Location : US-NJ-Piscataway
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
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