Scientist II - GC-MS

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.