Job Title: Scientist 3
This role is located at our Greenville, North Carolina site. Relocation assistance has been approved for the successful candidate.
Provides complex analyses in a chemistry or microbiological environment by selecting appropriate methods with independent judgement. Performs analytical methods for complex testing on raw materials, samples, stability, environmental, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial
limits tests, and/or and antimicrobial effectiveness tests. Supports internal development and/or manufacturing operations. Makes detailed observations and analyzes, resolves issues, documents, and communicates test results.
1. Verifies and processes analytical data. Facilitates development of quality products through participation and representation on group and department level project teams.
2. Conducts complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.
3. Leads the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and traditional wet chemical testing.
Determines which methods will be used.
4. Makes determination to resolve out-of-specification or unexpected results and analytical and product problems.
5. Maintains and troubleshoots analytical instrumentation as needed. Performs audits on equipment periodically to verify proper calibration and use.
6. Develops documentation processes. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance
with prescribed lab procedures and systems. Interacts with clients directly.
7. Leads, prepares, and files regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
8. Coordinates and leads writing of SOPs, policy manuals, and other instructional documents.
9. Cleans and organizes work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems after use.
10. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices,
Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards. Using the strong action verbs as exampled in item #3 below; add core essential job functions; end each item with a period. Specific product/program/project/vendor/report names should not be included.
Bachelor’s degree in physical science, preferably in Chemistry or Biology.
Typically requires a minimum of 5 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples.
Equivalent combinations of education, training, and relevant work experience may be considered.
Excellent knowledge and understanding of chemistry and analytical instrumental technologies. Excellent knowledge of qualitative and quantitative chemical analysis. Excellent understanding of quality and regulatory requirements in
the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Excellent problem solving skills and logical approach to solving scientific problems. Excellent proficiency with HPLC, GC, LC/MS and Dissolution techniques (method development and validation). Excellent interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees.
Good leadership skills. Ability to read, analyze, and interpret technical procedures and governmental regulations.
Ability to write standard operating procedures and policy manuals. Ability to respond to complex inquiries or complaints from customers or regulatory agencies. Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance, and correlation techniques.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry,
move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of
the EU Equality Directive, in relation to the recruitment and employment of its employees.