Associate Scientist, Analytical Chemistry

The Associate Scientist, Analytical Chemistry is an entry level, and it contributes to tasks associated to pharmaceutical analysis intended for drug product development. The preliminary activities include following schedules, direction of compendia standards and in-house standard operating procedures to analyze pharmaceutical drug substance, excipients, drug product testing for release and stability samples. The individual is a part of the Quality Control Technical Services team which perform release testing of API, Excipients/raw materials, In-process and Finished products and stability study, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents.

• 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.
• 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.
• Evaluate, recommend and implement new analytical technologies and instrumentation for testing

• →Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance. Leads team members on assigned projects, as required. Participates and leads scientific discussions on projects with cross-functional team. 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.

• Bachelors Degree (BA/BS) Chemistry or related pharmaceutical sciences - Required
• Master Degree (MS/MA) Chemistry or related pharmaceutical sciences - Preferred

• 1 year or more in pharmaceutical experience

• Knowledge of US FDA- cGMP and Standard Operating Procedures (SOP).
• Understanding of analytical chemistry and analytical laboratory procedures.
• Background of modern analytical laboratory techniques and use of HPLC, GC, TLC, UV, and analytical equipment.
• Some knowledge of analytical Method development. Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis. Must understand and apply cGMP requirements applicable to quality control laboratory. Some experience in cGMP laboratory testing of pharmaceuticals.

Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.

The base salary for this position ranges from $68,000 to $85,000 per year.   Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting.  Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.  At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.  We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.