Chemist- Pharmaceutical

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Location
Royston, GA
Salary
$60,000 - $80,000
Job Type
Direct Hire
Degree
Bachelor
Date
May 17, 2017
Job ID
2483886
The Chemist position is a key laboratory position in a GMP environment responsible for testing of raw materials, finished products, and stability samples. Chemists are active participants in new projects, such as method transfers and initiation of stability studies. This position reports to the Senior Laboratory Manager.
 
Primary Responsibilities:
o         Ensure that all analytical testing requirements are completed following safety standards with the necessary accuracy and within the expected timeframe.
o          Design and coordinate analytical special project activities for product evaluation, raw material evaluation, and process monitoring.
o          Maintain Analytical files and records in accordance with GMP and company standards.
o          Provide leadership in identifying areas of improvement, productivity gains, and potential problems in regards to Analytical concerns.
o          Coordinate all Analytical supply purchases and equipment repair through contact with approved vendors.
o          Be the true plant expert on Analytical issues.
o          Conduct complex chemical and physical analyses using both instrumental and classical analytical techniques.
o          Monitor and assure compliance of the laboratory to applicable company policies, procedures, compendial procedures, and current GMP regulations.
o          Train designated new/existing personnel to ensure the technical competency of personnel performing analytical testing (includes OSI in Powder        
Analytical Lab).
o          Evaluate new methods and instrumentation for feasibility/potential improvements, and make recommendations accordingly.
o          Develop plans and conduct projects of investigative and analytical nature, as necessary, to solve laboratory problems, maintain and/or improve analytical support to Operations.
o          Oversee the resolution of testing discrepancies and troubleshoots method and instrument problems.
o          Interface with personnel form other companies/laboratories regarding testing discrepancies and method/instrument problems.
o          Maintain inventory of chemicals, apparatus, and equipment for analytical laboratory and satellite laboratories.
o          Analyze test data generated by self and others, utilizing statistical techniques, for presentation to management as necessary.
o          Conduct complaint, validation, and inter-laboratory test method transfer sample testing according to procedures and established requirements.
o          Schedule monitoring, testing, documentation and reporting of stability samples according to established procedures in a timely manner.
o          Maintain the analytical lab and retain room in accordance with GMP/Plant housekeeping procedures.
o          Maintain all applicable equipment and instrumentation with calibration specifications.
 
Leadership Expectations:
o          Provide appropriate support to operational priorities whenever possible.
o          Demonstrate effective leadership to the laboratory staff.
o          Provide ideas and suggestions to improve laboratory operation.
o          Effectively resolve testing discrepancies and instrument problems in a timely manner.
o          Enforce the implementation of the laboratory's safety rules.
o          Initiate changes to test methods and specifications for purposes of updating, clarifying, and improving document requirements through the proper channels of approval.
o          Communicate problems/situations to supervisor in a timely manner and exercises good judgment in order to follow up effectively.
o          Interfaces effectively with members of QA organization, Planning, Operation, customers, etc.
o          Written reports are clear, concise, timely, of high quality, and free of unaddressed issues.
o          Can work with the laboratory staff to meet the desired departmental goals and objectives.
o          Offers possible solutions when presenting problems to the supervisor.
o          Promotes a culture of teamwork and collaboration.
 
Knowledge and Skills:
o          Bachelor's degree in science related course of study such as Chemistry or Biology
o          Minimum 5 years relevant in an Analytical Laboratory.  Minimum 3 years of experience in a GMP Pharmaceutical Laboratory.
o          Experience with wet chemistry testing and analytical instrumentation such as HPLC, GC, FTIR, UV is strongly desired.
o          Understand medical device/drug GMP's, company policies, and any associated safe laboratory practices.
o          Must have working knowledge of computer software such as Microsoft Word and Excel. Must also have knowledge of associated software used to operate laboratory equipment. Experience with ChemStation chromatography software is a plus.
o          Must be able to read and gain a thorough understanding of pertinent company and laboratory SOP's, specifications, and document change control systems.
o          Specialized knowledge and understanding of manufacturing processes and material characteristics.
o          Must have a working knowledge of the contents and use of various compendia (USP/NF, EP, ASTM, etc.).
o          Excellent communication skills within all levels of the organization and outside of the organization as required.
o          Must be able to handle conflict effectively, make a stand where appropriate, and reach agreements with business partners.
 
 
Must have:
 
1.  Bachelor's degree in science related course of study such as Chemistry or Biology.
2.  5+ years of relevant experience in an Analytical Laboratory including 3 years of experience in a GMP Pharmaceutical Laboratory. 
3.  Experience with wet chemistry testing and analytical instrumentation such as HPLC, GC, FTIR, UV is strongly desired. 
4.  Must have a working knowledge of the contents and use of various compendia (USP/NF, EP, ASTM, etc.).
 
5.  Experience with ChemStation chromatography software is a plus.