Associate Scientist, Analytical Chemistry

Amneal India•Brookhaven, NY

1d•$68,000 - $85,000

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 study, cleaning verification samples following written procedures and applicable SOPs, calculates and reports results on applicable specification documents.

Requirements

Entry level position
Ability to follow schedules
Ability to follow compendia standards
Ability to follow in-house standard operating procedures
Ability to analyze pharmaceutical drug substance, excipients, and drug product testing for release and stability samples
Ability to perform release testing of API, Excipients/raw materials, In-process and Finished products and stability study, cleaning verification samples
Ability to calculate and report results on applicable specification documents
Ability to comply with cGMPs, SOPs, and STPs
Ability to assure compliance with state and federal regulations
Ability to document steps followed during analysis execution
Ability to review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies

Nice To Haves

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

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.