JOB SUMMARY
The Scientist II sets up Extractables & Leachables studies and conducts quantitative and qualitative analyses according to FDA, cGMP, and Boston Analytical Inc. Standard Operating Procedures. Duties include analysis of extract and pharmaceutical product samples using LC-MS, GC-MS, and/or ICP-MS. A Scientist I will also develop and validate leachables methods for these techniques.
PRIMARY DUTIES AND RESPONISIBITIES
- Prepares and analyzes samples and sample extracts to detect and identify extractables from pharmaceutical packaging and leachables from drug product samples.
- Coordinate findings with team members.
- Maintain and calibrate analytical equipment following established procedures.
- Author detailed cGMP report sections for work performed.
- Develop and validate leachables methods for LC-MS, GC-MS, and/or ICP-MS.
- Train other team members on the various techniques performed in the E&L lab.
- Write, maintain, and edit departmental Standard Operating Procedures.
- Perform peer review of work from other team members.
- Perform assigned tasks and duties independently with minimal supervision.
- Prepares samples for analysis by GC-MS.
- Analysis of sample solutions by liquid injection and headspace GC-MS to adequately resolve and identify all compounds.
- With the help of the NIST library, identify detected extractables.
- Incorporate data into detailed, concise analytical report along with data from other techniques.
- Develop GC-MS methods for drug product stability testing.
- Performs system maintenance and calibrations to ensure equipment is operating within specified requirements. Ensures all work performed strictly adheres to Company, client and Pharmacopial requirements.
- Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
REQUIREMENTS & QUALIFICATIONS
B.S. in Chemistry or related discipline with 3+ years’ experience performing GC-MS analysis or a master's with 1-3 years of experience. Knowledge of cGMPs and related compliance regulations and guidance required. Experience working in a cGMP laboratory.
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.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.
- Demonstrated ability to perform analysis using GC-MS.
- Strong drive to learn and improve current skill set.
- Documented success managing multiple tasks and deadlines to successful completion that is within customer expectations.
