Senior Scientist – Protein Therapeutics
The Senior Scientist conducts quantitative and qualitative analysis of protein therapeutic products according to FDA, cGMP and Boston Analytical, Inc. procedures. 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 LC-MS, HPLC and other appropriate techniques.
Primary Duties and Responsibilities
- Develop and apply product specific sample preparation and analysis methods for protein/peptide therapeutic products primarily utilizing chromatography and mass spectrometry.
- Troubleshoot analytical methods.
- Conduct experiments to ascertain quality attributes for protein therapeutic products, such as amino acid sequence, total protein, and protein structure and modifications.
- Produce analyze and interpret analytical data. Perform advanced data generation, analysis and complicated problem solving independently with minimal rework.
- Design, plan and execute assay development, validation and transfer projects.
- Write validation protocols and validate LC-MS methods according to ICH validation guidelines.
- Prepare reports and technical data summaries, present and communicate results to collaborators.
- 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.
- Supervises, 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.
- Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
- Advanced degree – a PhD, Master’s or Bachelor’s degree in Chemistry or a related discipline.
- Must have laboratory experience with a minimum of 2+ years of experience related to protein drug development, or 5+ years of experience 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.
- Knowledge and understanding of mass spectrometry techniques as related to protein analysis.
- Hands on experience with protein analytical method development, particularly in chromatographic methods in combination with mass spectrometry.
- Knowledge of cGMPs along with ICH and related compliance regulations and guidance, 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.
- 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.