Amneal Pharmaceuticals · 2 weeks ago
Senior Scientist, Quality Control
Brookhaven, NY
Full-time
Onsite
Mid, Senior Level
$90K/yr - $95K/yr
3+ years expAmneal Pharmaceuticals is a company focused on quality control in the pharmaceutical industry. They are seeking a Senior Scientist to perform testing of raw materials and finished products, ensuring compliance with regulations and company policies while contributing to continuous improvement efforts.
ManufacturingMedicalPharmaceutical
Responsibilities
Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations
Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required
Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator
Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results
Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies
Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications
Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory
Ensure that expired chemicals and reference standards are removed from laboratory area
Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor
Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels
Qualification
Required
Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
With a Bachelors Degree (BA/BS) -5 years or more of testing of chemicals/pharmaceutical products
With a Masters Degree (BA/BS) -3 years or more of testing of chemicals/pharmaceutical products
Must be precise and consistent in day to day analysis, easily trainable and ready to learn. - Advanced
Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Advanced
Must be able to execute compendial procedures involving complexity with no or minimal supervision. - Intermediate
Must be able to effectively communicate results, problems or issues, verbally as well as in writing. - Intermediate
Must be able to assume a role of a leader in team environment as and when required. - Intermediate
Must be computer literate and savvy with MS office applications, software programs related to LIMS. - Intermediate
Must be willing to work extended hours, including weekends, as and when required. - Intermediate
Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Advanced
Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Advanced
Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. - Advanced
Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. - Intermediate
Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques)
Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis
Must understand and apply cGMP requirements applicable to quality control laboratory
Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner
Must be able to identify trends in analytical data
Preferred
Master Degree (MS/MA) Chemistry or related science discipline - Preferred
Benefits
Above-market, diverse and robust health and insurance benefits
Significant 401(k) matching contribution
Programs that helps you enjoy your career alongside life’s many other commitments and opportunities
Company
Amneal Pharmaceuticals
Amneal Pharmaceuticals manufactures, markets and/or distributes more than 88 drugs in the United States.
5001-10000 employees
H1B Sponsorship
Amneal Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (25)
2024 (32)
2023 (33)
2022 (33)
2021 (42)
2020 (34)
Funding
Current Stage
Public CompanyTotal Funding
$3.2B2023-11-16Post Ipo Debt· $2.35B
2018-05-07IPO
2017-10-01Post Ipo Equity· $854M
Leadership Team
Chirag Patel
President & Co-Chief Executive Officer
Recent News
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