Senior Scientist – Method Development and Validation
The Senior Scientist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. The position includes development of analytical methods and attendant procedures, as well as validation of analytical methods, including writing validation protocols and reports. Techniques will include analysis of pharmaceutical products using chromatographic techniques, spectrographic techniques, thermal analysis, and wet chemical analysis.
Primary Duties and Responsibilities
- Develops methods based on client requirements. Specific techniques include, but are not limited to HPLC, GC, AA, FTIR, and dissolution.
- Conducts research on manufactured products to develop, improve and validate test procedures.
- Validates methods compliant with regulatory requirements.
- Generates protocols and reports for method development, validation, and transfer.
- Conducts independent assessment of method performance and address issues.
- Devises and develops processes and methods for the solution of technical problems.
- Confers with chemists and client personnel regarding research, procedures performed, related results, and prepares technical papers, protocols and reports.
- Follows all safety rules and regulations and conducts periodic safety audits.
- Ensures all appropriate work is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration and United States Pharmacopeia or other compendial methodologies.
- Trains, and mentors other chemists on an as needed basis.
- Provides planning and oversite on projects, establishing the approach, required resources, timing and meeting agreed timelines.
- Performs work at a level considered subject matter expert. As subject matter expert, confers with Quality Assurance and Lab Management to design and/or improve procedures and/or training programs.
- Performs advanced data generation, analysis and 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.
- Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
- This position requires a PhD, Master’s or Bachelor’s degree in Chemistry or a related discipline.
- Must have laboratory experience with a minimum of 5+ years of experience related to small molecule drug development, combined with a Master’s degree as described above; or a minimum of 8+ years of related work experience combined with a Bachelor’s degree as described above, or 2+ years combined with a PhD in a relevant discipline.
- Experience with analytical method development, particularly in chromatographic methods.
- Knowledge of cGMPs and related compliance regulations and guidances required, especially around requirements for analytical method development and validation.
Minimum Skills Requirements:
- Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
- Must be capable of interactions with clients in presentations and in technical discussions pertaining to prospective or ongoing projects.
- 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 writing ability and 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.