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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 II 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.