HireDiversity

Athens, GA, US

Senior Analytical Scientist (1 of 2)-8751120912

Description

Noramco, Inc., a member of Johnson & Johnson's family of companies, is recruiting for a Senior Analytical Scientist to be located in Athens, GA.

Noramco, Inc. produces a variety of active pharmaceutical ingredients and is a major worldwide producer of medicinal analgesics, pharmaceutical intermediates and synthetic fine organic chemicals. It also produces monomers and polymers for pharmaceutical and medical devices.

The Senior Analytical Scientist provides analytical support services as part of the Scientific Affairs Organization by conducting research in assigned areas using established methodology or by developing new methodologies under the guidance of more senior scientists or the department manager. Specific responsibilities include: analysis of research samples; validation, maintenance and improvement of existing methods; and development of new analytical methods for existing, transferred and new products. Incumbents will partner with Process Development, New Product Development and Introduction, Regulatory Affairs, Quality Control and Operations groups.

This position will be responsible for performing 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 and accurately performing general analytical techniques and operating analytical equipment such as HPLC, GC, HPLC/MS, GC/MS, X-Ray Diffraction, Particle Size Laser Diffraction. This role troubleshoots non-routine equipment issues and independently interprets spectra and data results utilizing overall general knowledge of each of these instruments, and advanced in-depth knowledge of 1 to 2 of these instruments and techniques. The Sr. Analytical Scientist will train others on general laboratory techniques and procedures and assist in the evaluation and implementation of new technologies and instrumentation.

This position will manage analytical elements of projects such as new product introductions, implementation of new analytical methodologies or techniques and support routine and non-routine quality investigations, plant process troubleshooting, 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). The Sr. Analytical Scientist will maintain existing analytical methods and procedures, and develop, validate, and transfers new, routine and non-routine analytical test methods; and will be responsible for the development of validation protocols, test procedure documentation, and complete technical reports that conform to Noramco standard procedures and requirements that include data based and technically-sound recommendations, requiring minimal corrections.

The Senior Analytical Scientist 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 and will be responsible for reviewing fellow Scientist's work, including complex records of experimentation, to ensure completeness and accuracy. This position provides analytical advice and consultation on routine and non-routine analytical chemistry technical issues in areas of expertise and will consult more senior scientists and management where appropriate. The Senior Analytical Scientist plans, designs, and conducts research within area of expertise and coordinates and partners with internal and external customers for transfer and implementation of new methods and technologies. This position also analyzes and interprets the results, and summarizes findings for presentation; collaborating and consulting with more senior scientists and managements as needed.

The Senior Analytical Scientist will provide solutions to problems of limited to moderate scope and complexity and exercises judgment within generally defined policies and procedures to determine appropriate action. This position will routinely interact with internal laboratory personnel and support vendors as necessary; and may interact with external customer or business partners and contract labs as necessary. On a project basis, this role may assist with the procurement, installation and calibration of laboratory instruments, equipment and supplies to ensure reliable, prompt, precise and accurate test data; and may also assist with the setup, IQ, OQ and PQ of new equipment.

The Senior Analytical Scientist interfaces with operations and technical personnel and trains new laboratory personnel, as well as other employees, in Noramco procedures/processes and equipment, and new processes/technology depending on area of expertise in accordance to internal procedures and guidelines; and practices continuous improvement in the development of new or refined materials, processes, products and/or scientific/business procedures and processes. The Senior Analytical Scientist makes decisions regarding analyzing and interpreting data, drawing conclusions, and arriving at timely technical decisions and performs other appropriate duties as assigned by the Analytical Services Manager.

This position requires a 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 associated with NORAMCO, Inc. The Senior Analytical Scientist will have a 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 and maintains an adequately supplied, properly cleaned and safe laboratory to minimize test delays, test errors and mishaps by using good laboratory and housekeeping practices. This position requires the ability to make independent decisions and works under minimal supervision. Additionally, this role will 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; observing and promoting 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. This position also assumes the responsibility for environmental effects of work performed and for the identification and recording of environmental problems as they arise and understands and responsibly performs duties with attention to quality, safety and environmental matters including: wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), plus all other relevant job requirements.

Qualifications


A minimum of a Bachelor's degree in Chemistry or a related science is required. A Masters or Ph.D is highly preferred. A minimum of 6 years of related experience in instrumental and wet chemical techniques is required. Knowledge of cGMP/cGLP regulations and chemical manufacturing practices/processes is required. Knowledge of analytical instrumentation use and routine preventative maintenance is required. Experience in most of the following techniques (HPLC, HPLC Mass Spectrometry, GC, Particle Size Analysis, XRPD) is preferred. The ability to trouble-shoot moderately complex and non-routine instrumentation malfunctions following ICMS investigation protocols will be needed. Knowledge of computer software and customized programs usage to meet business needs, including word processing and mathematical applications, is preferred. The ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production will be needed. 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 is required.

The successful candidate must have the ability to make independent decisions within standard guidelines and to work under general supervision; maintain an adequately supplied, properly cleaned and safe laboratory to minimize test delays, test errors and mishaps by using good laboratory and housekeeping practices and 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. The successful candidate must be available for overtime work on a scheduled or emergency basis.

The following physical demands are required to be completed for the successful candidate: the employee is frequently required to stand; walk; use hands to finger, handle, or feel; the employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; the employee must occasionally lift and/or move up to 10 pounds; specific vision abilities required by this job include close vision, color vision, and ability to adjust focus and the employee must be able to qualify for respiratory protective equipment use.

This position is based in Athens, GA.

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Primary Location:North America-United States-Georgia-Athens
Organization: Noramco, Inc. (6109)