The Scientist 3 - QCTS is responsible for performing all analytical method development, qualifications and method validations for active pharmaceutical ingredients, excipients, and the finished product pharmaceutical dosage forms. This individual performs testing of in-process and release activities to support post approval changes related to manufacturing and raw material/packaging component related changes. This role will support all testing related to alternate source qualification of API, excipients, and packaging components. This role will also support testing required for continuous compliance to applicable monographs and compliance to all existing and new guidance. This individual will participate in method transfer activities within departments or between facilities or organizations. This individual analyzes organic or inorganic compounds using chromatography, spectroscopy or spectrophotometry techniques and conduct quality control tests. This individual maintains laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed. The Scientist-3 assists Group Leader/Manager with training other scientists for analytical instrument/equipment.
Essential Functions:
Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, according to written methods, protocols, material specification, and company policies as identified in standard operating procedures (SOPs) to support method validation/verifications. Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations.
Perform testing using HPLC, UPLC, GC, ICPMS, ICP-OES, GCMS, LCMS, IR, UV, Malvern Mastersizers, XRD, Dissolution, Karl-Fischer titrator, analytical balances, and other instruments as required.
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.
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.
Additional Responsibilities:
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.
Education:
Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
Master Degree (MS/MA) Chemistry or related science discipline - Preferred
Experience:
5 years or more in Bachelors Degree (BA/BS) -Testing of chemicals/pharmaceutical products
3 years or more in Masters Degree (BA/BS) -Testing of chemicals/pharmaceutical products
Skills:
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
Specialized Knowledge:
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.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
