Senior Analytical Chemist – Raw Materials
The Senior Analytical Chemist will perform analytical analysis of raw materials, including volatile and non-volatile chemicals, active pharmaceutical ingredients, excipients, impurities/residues, and reagents according to compendial and Boston Analytical, Inc. Standard Operating Procedures. Duties will include but not be limited to compendial analysis and method development of raw materials within the raw material laboratory.
Primary Duties and Responsibilities
- Set-up, perform, and/or supervise analytical testing.
- Prepares samples for analysis by wet chemistry, titration, physical characterization, and instrumentation.
- Analysis of sample solutions to adequately resolve and identify all compounds.
- Coordinate findings with sample data from a variety of analyses, including GC and HPLC analyses.
- Author analytical protocols and detailed cGMP reports outlining study findings.
- Performs system maintenance and calibrations to ensure equipment is operating with specified requirements. Ensures all work performed strictly adheres to Company, client and Pharmacopeial requirements.
- Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
- Confers with chemists and other client personnel regarding research, procedures performed and related results and prepares technical papers and reports.
- As a subject matter expert, confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
- Provides over site to projects and assist other Analysts 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.
- Supervises, trains, and mentors other chemists on an as needed basis.
- 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.
Qualifications include a Bachelors Degree in Chemistry with 5+ years’ of relatable experience or a Master’s Degree in Analytical Chemistry with 4+ years’ of relatable experience. Strong knowledge of cGMPs and related compliance regulations and guidance 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.
- In depth knowledge in chemistry principles and compendial methodologies, including regulatory requirements and compendial performance criteria.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.
- Demonstrated skills in testing operation and data interpretation capability.
- Ability to develop and optimize analytical methods and trouble shoot issues/problems.
- Documented success managing complex projects to completion within customer expectations for deadline, cost, and overall deliverable.