Analytical Chemist III
The Senior Chemist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development.
Primary Duties and Responsibilities:
- As subject matter expert, confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
- Devises and develops processes and methods for the solution of technical problems.
- Confers with chemists and other client personnel regarding research, procedures performed and related results and prepares technical papers and reports.
- Supervises, trains, and mentor’s other chemists on an as needed basis.
- Prepares and analyzes products to determine chemical and physical properties.
- Provides oversight to projects and assist other Chemists as needed.
- Performs advanced data generation, analysis and solves complicated problem solving independently with minimal rework.
- Reviews and assesses discrepancies; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting.
- Ensures all work performed is performed in compliance with standard operating procedures, good manufacturing practices, regulations of the Food and Drug Administration.
- Ensures all work performed strictly adheres to Company, client and Pharmacopial methodologies.
Qualification include a Bachelor’s degree in Chemistry or a related discipline with a minimum of 3+ years of related work experience required. Knowledge of cGMPs and related compliance regulations and guidances required.
Minimum Skills Requirements:
- Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
- A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
- Must have excellent organizational, verbal communication and technical documentation skills.
- Solid computer skills.
- Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members. Ability to be an effective hands-on leader.
- Documents work in a clear and organized manner.
- Follows all safety rules and regulations and conducts periodic safety audits.
- Follows all cGMP rules and regulations.