Job Title: Chemist

Work Location: Montgomery County, Pennsylvania

Summary:

Seeking skilled individuals with knowledge, training, and daily practice of quality principles. The individual must be hard working, ambitious, and able to learn and manage/prioritize responsibilities in a dynamic business environment. The analytical group is responsible for the analysis of raw materials, in-process materials, stability, and finished products in conformance with cGMP regulations. The group is also responsible for scheduling, calibration, and maintenance of equipment, as well as method development and validation for various analytical methods. As a member of the team, you will follow and help plan daily operations within the lab and communicate with all areas to meet client and company deadlines.

Responsibilities:

• Expertise with analytical instrumentation, HPLC, UHPLC, Dissolution, Spectrophotometer, GC, KF (potentiometric and coulometric), ICP-MS, Viscometers, etc
• Knowledge and experience of USP, ICH and CFR regulatory requirements
• Expertise with analytical techniques, Method Development/Validation, chromatography, pipetting, solution preparation, etc
• Expertise in electronic systems, LIMS, electronic laboratory notebook, TrackWise, OpenLAB, Excel, Word, Authoring monographs, etc
• Perform various analytical tests, Assay, dissolution, degradants, moisture, hardness, viscosity, pH, etc
• Execute against monographs, protocols, and SOPs in a cGMP laboratory environment
• Prevent deviations and investigations
• The ability to conduct stability scheduling and studies
• Adhere to deadlines in a changing environment
• Ability to learn and teach laboratory techniques
• Schedule work based on priorities and manage time efficiently
• Perform general laboratory maintenance and cleaning
• Work collaboratively in cross-functional teams
• Liaise with customers, staff and suppliers
• Be aware of, and keep up to date with, health and safety issues
• Maintain laboratory inventory
• Prepare documentation for product license applications/regulatory filings
• Practice continuous improvement
• Develop business through new quotations, seek new clients, and interact with current clients
• Responsible for training employees in lab techniques and cGMP procedures
• Must be a self-starter and capable of working with minimal oversight
• Create value for the position, department, and company
• Improve systems and procedures to prevent errors
• Work in a fast paced and challenging environment
• Salaried employees are compensated for a 50 hour work week

Qualifications:

• Minimum of a Bachelor’s Degree in chemistry from an accredited US college or university
• 3+ years of previous related lab experience
• Expertise with analytical instrumentation, including HPLC, UHPLC, Dissolution, Spectrophotometer, GC, KF (potentiometric and coulometric), ICP-MS, Viscometers, etc
• Knowledge and experience of USP, ICH and CFR regulatory requirements
• Experience with analytical techniques, method development/validation, chromatography, pipetting, solution preparation, etc
• Experience with electronic systems, LIMS, electronic laboratory notebook, TrackWise, OpenLAB, Excel, Word, authoring monographs, etc
• Ability to perform various analytical tests (assay, dissolution, degradants, moisture, hardness, viscosity, pH, etc.)
• Ability to execute against monographs, protocols, and SOPs in a cGMP laboratory environment
• Ability to prevent deviations and investigations
• Ability to conduct stability scheduling and studies
• Ability to adhere to deadlines in a changing environment
• Ability to learn and teach laboratory techniques
• Ability to schedule work based on priorities and manage time efficiently
• Ability to perform general laboratory maintenance and cleaning
• Ability to work collaboratively in cross-functional teams
• Ability to liaise with customers, staff, and suppliers
• Awareness of, and ability to keep up to date with, health and safety issues
• Ability to maintain laboratory inventory
• Ability to prepare documentation for product license applications/regulatory filings
• Commitment to continuous improvement
• Ability to develop business through new quotations, seek new clients, and interact with current clients
• Experience training employees in lab techniques and cGMP procedures
• Self-starter, capable of working with minimal oversight
• Ability to create value for the position, department, and company
• Ability to improve systems and procedures to prevent errors
• Ability to work in a fast-paced and challenging environment

Published Category: Analytical & Process Development