Chemist I, Biological Macromolecules
The Chemist in the Biological Macromolecules laboratory conducts quantitative and qualitative analysis of protein therapeutics according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. The position includes assisting Scientists in development of analytical methods and attendant procedures, as well as validation of analytical methods. Techniques will include analysis of pharmaceutical products using microtiter plate methods such as ELISA, capillary electrophoresis, HPLC and other appropriate techniques. The Chemist will perform data processing and analysis related to the laboratory work. **This position will be located in Framingham, MA.**
Primary Duties and Responsibilities
- Executes analytical methods according to written standard operating procedures or protocols, using techniques such as UV/Visible spectroscopy, HPLC, qPCR or electrophoresis.
- Analyzes data generated in the laboratory to determine the validity of test runs and to determine the outcome of the experiments.
- Performs routine maintenance in the lab, including instrument care.
- 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.
- Performs proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
- A Bachelor’s degree in Biology, Chemistry or a related discipline.
- Must have laboratory experience with 0-2 years of experience related to protein drug development.
- Knowledge and understanding of microtiter plate-based spectrometery, HPLC, capillary electrophoresis, qPCR or mass spectrometry techniques as related to protein analysis.
- Hands on experience with protein analytical method development, particularly in ELISA or chromatographic methods.
- 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 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.
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