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13 days old

Method Development Chemist - Scientist

Kelly Services
Cary, NC 27512
**Kelly Services is actively recruiting for a Senior Analytical Scientist (Method Development Chemistry) in Cary, NC. This is a Direct Hire (perm) opportunity!**


The Senior Analytical Scientist will provide Analytical Services as part of the Analytical Services Team by conducting research in assigned areas using established methodology or by developing new methodologies under the guidance of more senior Scientists or Department Manager.


Specific responsibilities include the following: analysis of research samples; validation and improvement of existing methods; development of new analytical methods for existing, transferred, and new products.


+ Performs analytical chemistry work necessary to ensure the identity, purity, quality and strength of materials, by following established test methods and procedures and developing new test methods and procedures where necessary.

+ Has full working knowledge of all analytical testing activities as they pertain to products and procedures

+ Effectively and accurately performs general analytical techniques and operates analytical equipment (such as HPLC, GC, HPLC/MS, KF, pH, DSC, FTIR), troubleshoots non-routine equipment issues and independently interprets spectra and data results. Has overall general knowledge of each of these instruments and has advanced in-depth knowledge of 1 to 2 of these instruments and techniques.

+ Can train others on general laboratory techniques and procedures.

+ Assists in the evaluation and implementation of new technologies and instrumentation.

+ Manages analytical elements of projects such as new product introductions, implementation of new analytical methodologies or techniques.

+ Supports routine and non-routine quality investigations, process development activities and assessment of unusual process/testing occurrences by performing analytical testing and problem-solving activities. This type of analytical work may depend on methods without established and approved test procedures.

+ Maintains existing analytical methods and procedures, and develops, validates, and transfers new, routine and non-routine analytical test methods. Activities include the development of validation protocols, test procedure documentation, and complete technical reports that conform to standard procedures and requirements. Technical reports must include recommendations that are data based and technically-sound, requiring minimal corrections. Working knowledge with documentation and associated systems.

+ Maintains and provides notebooks, records, reports, action/check lists and documentation which are current, legible, readily understood, complete and accurate to ensure compliance with established procedures and specifications and are verifiable as required or requested. Reviews fellow Scientist's work, including complex records of experimentation, to ensure completeness and accuracy.

+ Provides analytical advice and consultation on routine and non-routine analytical chemistry technical issues in areas of expertise. Consults with more senior scientists and management where appropriate.

+ Coordinates and partners with internal and external customers for transfer and implementation of methodology within area of expertise.

+ Plans, designs, and conducts research within area of expertise. Analyzes and interprets the results and summarizes findings for presentation. Collaborates and consults with more senior scientists and management as needed.

+ Provides solutions to problems of limited to moderate scope and complexity. Exercises judgment within generally defined policies and procedures to determine appropriate action. Consults more senior scientist and management as appropriate.

+ Routinely interacts with internal laboratory personnel and support vendors as necessary. May interact with external customer and contract labs as necessary.

+ On a project basis may assist with the procurement, installation and calibration of laboratory instruments, equipment and supplies to ensure reliable, prompt, precise and accurate test data. May assist with the setup, IQ, OQ and PQ of new equipment.

+ Trains new laboratory personnel in procedures/processes and equipment. May train others in new processes/technology or equipment depending on area of expertise in accordance to internal procedures and guidelines.

+ Practices continuous improvement in the development of new or refined materials, processes, products and/or scientific/business procedures and processes.

+ Makes decisions regarding analyzing and interpreting data, drawing conclusions, and arriving at timely technical decisions.

+ Performs other appropriate duties as assigned by the Manager.

+ Interfaces with operations and technical personnel.

+ Requires thorough understanding and advanced knowledge of all test methods, procedures, instruments and apparatus for the receipt, labeling, sampling, testing, documentation, release and distribution of all chemical substances,

+ Complete understanding and working knowledge of computerized data acquisition, analysis and handling techniques to ensure reliable, prompt, precise and accurate test data using established methods and procedures.

+ Maintains an adequately supplied, properly cleaned and safe laboratory to minimize test delays, test errors and mishaps by using good laboratory and housekeeping practices.

+ Ability to make independent decisions within general guidelines and to work under minimum supervision.

+ Maintain and comply with all regulatory programs and guidelines to ensure that all current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) requirements are met.

+ Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority.

+ Follows all applicable aspects of the site Environmental Management System as it pertains to normal job duties. Assumes responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.

+ Complies with all regulatory and job training requirements to perform duties of the job.

+ May perform other duties as assigned.


**Education and/or Experience**


+ Bachelors degree in Chemistry or related field with an emphasis on analytical chemistry

+ 6+ years quality control experience working in a cGMP environment

+ Advanced knowledge of cGM/cGLP regulations and chemical manufacturing practices/processes is required.

+ Advanced knowledge of analytical instrumentation use and routine preventative maintenance. Ability to trouble-shoot moderately complex and non-routine instrumentation malfunctions following the investigation protocols.

+ Use computer software and customized programs to meet business needs, including word processing and mathematical applications.

+ Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.

+ Must be able to work with people, influencing their output and work behavior.

+ Must be able to work in situations where speed and sustained attention are essential, performing a variety of tasks without loss of production.

+ Ability to perform under stress in cases of emergency, critical or hazardous situations.

+ Experience in most of the following techniques: HPLC, HPLC Mass Spectrometry, GC, Particle Size Analysis, XRPD.


\#TJP2022_SPEC


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-06 Expires: 2022-06-06

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Method Development Chemist - Scientist

Kelly Services
Cary, NC 27512

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