R&D/Mfg Scientist III Position Available In Pitt, North Carolina

R D/Mfg Scientist III
Location Greenville, North Carolina, United States of America Job Id

R-01318776

Job Type Full time Category Research & Development Remote Fully Onsite
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
How will you make an impact?
Investigate, create, and validate new scientific methodologies used to control raw materials, production intermediates, and final products on a complex scope of projects.
Work on technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations.
May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development.
Participate in technical discussions with clients with a high level of technical proficiency.
Typically work in a specific scientific area, such as analytical development, process validation, formulations, and/or manufacturing technical support.
Make decisions that require developing new options to solve complex problems.
What will you do?
Lead the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, potency, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and compendial testing. Support internal development and/or manufacturing operations.
Make detailed observations and analyze, resolve issues, document in accordance with prescribed lab procedures and systems, and communicate test results. Provide complex analyses in a chemistry environment by selecting appropriate methods with independent judgment and participate in development of scientific strategy.
Make determination to resolve out-of-specification or unexpected results and analytical and product problems. Maintain and troubleshoots analytical instrumentation as needed. Perform audits on equipment periodically to verify proper calibration and use.
Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.
May Lead projects without supervision; may lead multiple projects, including managing project timelines and deliverables.
May lead meetings/teleconferences with clients. Coordinate development of methods and processes that meet or exceed the expectations from clients and provide innovation as necessary.
Liaise with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
Contribute to the department’s talent acceleration by training Junior Scientists.
How will you get here?
Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science. Typically requires 8 years of progressive scientific experience, including 5 years in a related life sciences field in pharmaceuticals, if related master’s degree, typically requires 6 years of related experience. If related PhD, typically requires 3 years of experiences.
Knowledge, Skills, Abilities
Excellent knowledge and understanding of chemistry and analytical instrumental technologies.
Excellent knowledge of qualitative and quantitative chemical analysis.
Excellent problem-solving skills and logical approach to solving scientific problems.
Excellent proficiency with HPLC, GC, LC/MS and Dissolution techniques (method development, validation and transfer)
Experience in small molecules (Finished Product and/or API) required.
Excellent proficiency Dissolution techniques preferred but not required.
Experience in Biologics (SEC, RP, Peptide Mapping, SDS, Elisa, iCEF), sterile Liquids and/or Lyo for injections preferred but not required.
Experience in Empower preferred.
Experience in writing investigations, CAPA, Deviations.
Exceptional understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs. Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to write standard operating procedures and policy manuals.
Excellent interpersonal and communication skills (both oral and written).
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills.
Ability to work on multiple projects simultaneously. Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Ability to keep current with scientific literature and industry trends relating to process technologies. Ability to develop technical solutions.
Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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