Analytical Chemist

Sever Pharma Solutions•Putnam, CT

2d•$75,000 - $80,000

About The Position

Performs sample analysis using LC/GC and other analytical instruments daily, adhering to in-house or client test methods and USP/NF or EP general chapters and monographs. Assists with analytical test methods development for trace product analysis, assays, and impurities of final products. Drafts method development reports and method validation, verification, or method transfer protocols and reports. Supports assays and investigations/troubleshooting for raw material, in-process, and final product release in accordance with specifications and procedures. Assists in implementing new laboratory procedures and performs calibration and maintenance of laboratory equipment and instrumentation. Prepares and/or reviews Standard Operating Procedures, technical reports, specifications, stability protocols, and analytical test records. Prepares statistical analysis of results and assists with technical reports. Identifies and corrects nonconformances for laboratory procedures and analytical testing. Assists with problem-solving within the department and as a member of cross-functional teams, promoting quality achievement and performance improvement. Observes and maintains quality systems, policies, and procedures to ensure compliance with cGMP, GLP, ISO 9001/13485, FDA (i.e. 21CFR11, 820, 210, 211), and other applicable standards.

Requirements

Background and understanding for working in a Regulated (ISO, FDA and EU cGMP) environment.
Knowledge in utilizing LC/GC and common laboratory instruments.
Other techniques include: FTIR, UV-Vis Spectrophotometry, dissolution, pH, viscosity, moisture, titrations, and other wet and instrumental compendial testing
Knowledge of pharmaceutical analytical testing is highly desirable.
Knowledge of plastics manufacturing and associated analytical testing is highly desirable.
Demonstrates interpersonal, communication, and motivation skills.
Attention to detail is crucial in this position.
Flexible in handling multiple and changing work assignments.
Ability to effectively present information and respond to questions.
Knowledge of Excel, Word, PowerPoint.
Knowledge of analytical chemistry and other scientific disciplines generally attained through studies resulting in a degree.
M.S. or B.S. (minimum), in chemistry, science, biochemistry, or its equivalent is preferred.
A M.S. with a minimum of 1 years’ experience or a B.S. minimum of 2 years’ experience in pharmaceutical/medical device regulated environment.

Responsibilities

Performs sample analysis using the LC/GC and other analytical instruments on a daily basis using in-house or client’s test methods and USP/NF or EP general chapters and monographs
Assists with analytical test methods development for trace product analysis, assays, impurities of final products, as applicable
Drafts method development reports
Drafts method validation, verification, or method transfer protocols and reports
Assists in assays and investigations/troubleshooting problems which support the raw material, in-process and final product release in accordance with specifications and procedures
Assists in the implementation of new laboratory procedures
Assists and/or performs calibration and maintenance of Laboratory equipment and instrumentation including the oversight of Contract support for these activities, if required
Prepares and/or reviews Standard Operating Procedures, technical reports, specifications, stability protocols, and analytical test records, as applicable
Prepares statistical analysis of results and assists with technical reports
Identifies and corrects nonconformances for laboratory procedures and from analytical testing
Assists with problem solving within the department and as a member of cross functional teams
Promotes quality achievement and performance improvement
Observes and maintains quality systems, policies and procedures that ensure compliance to cGMP, GLP, ISO 9001/13485, FDA (i.e. 21CFR11, 820, 210, 211) and other applicable standards.