Associate Scientist, Analytical Chemistry

Amneal

1d

About The Position

The Associate Scientist, Analytical Chemistry is an entry-level position that contributes to tasks associated with 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, and drug product testing for release and stability samples. The individual is a part of the Quality Control Technical Services team which performs release testing of API, Excipients/raw materials, In-process and Finished products, and stability studies, cleaning verification samples following written procedures and applicable SOPs, calculates and reports results on applicable specification documents.

Requirements

• Bachelors Degree (BA/BS) Chemistry or related pharmaceutical sciences - Required
• 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.
• 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.
• This position requires successful completion of an OSHA-compliant Respirator Fit Test.

Nice To Haves

• Master Degree (MS/MA) Chemistry or related pharmaceutical sciences - Preferred
• Some knowledge of analytical Method development.

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 situations.
• 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 teams.
• 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.

Benefits

• Above-market, diverse and robust health and insurance benefits
• Significant 401(k) matching contribution
• Programs that help you enjoy your career alongside life’s many other commitments and opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level