R&D/Mfg Scientist II

Thermo Fisher Scientific•Greenville, NC

About The Position

The R&D Scientist II performs routine analyses in chemistry and biochemistry under defined procedures and practices. The role conducts moderately sophisticated analytical testing of samples, stability materials, and production intermediates to support process development and manufacturing operations. The scientist may research and implement methods and technologies to improve operations, and is responsible for making detailed observations and reviewing, documenting, and communicating test results. The position develops, evaluates, validates, and transfers test methods; performs testing and cGMP data review; maintains instrument calibration and verification; and supports compliance with regulatory requirements, ICH guidelines, USP/EP Pharmacopeia, GMP, and data integrity standards. The scientist may author or review investigations, change controls, technical documents, and procedures, assist with training as a subject-matter expert, coordinate project status with project leads and management, and participate in client meetings. All duties must comply with applicable SOPs, GMP, GLP, and safety guidelines.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology, or a related physical or biological science field, with at least 3 years of related experience; alternatively, a master’s degree with at least 1 year of related pharmaceutical industry experience.
Experience with HPLC.
Good knowledge and understanding of chemistry and analytical instrumental technologies.
Good knowledge of qualitative and quantitative chemical or microbiological analysis.
Awareness of pharmaceutical industry quality and regulatory requirements.
Strong interpersonal and written and oral communication skills.
Ability to read, analyze, and interpret technical procedures and governmental regulations.
Excellent organization and planning skills.
Strong attention to detail and ability to follow standard procedures.
Ability to design and complete tasks and studies based on deliverables.
Ability to accurately document work and write reports.
Fluency in English.
Ability to meet the physical requirements of the role, including prolonged periods of standing, walking, stooping, kneeling, crouching, typing, using a computer, operating equipment, reading, sitting, reaching, talking, and hearing; and manipulating light to medium weights of 10–35 pounds.

Nice To Haves

Master’s degree with at least 1 year of related pharmaceutical industry experience.
Experience with GC, dissolution, FT-IR, UV, Karl Fischer titration, IEF, ELISA, CGE, or Dot-Blot.
Experience performing method development and validation, and chemical tests using chromatographic, spectroscopic, or other analytical techniques.
Experience with Empower.

Responsibilities

Lead or execute the development, evaluation, validation, and transfer of test methods for pharmaceutical raw materials and finished products.
Test pharmaceutical raw materials and finished products for strength, impurities, identity, potency, and dissolution using HPLC, GC, IEF, CGE, and compendial methods.
Recognize and report out-of-specification or unexpected results and non-routine analytical or product problems.
Determine whether reported data meets specifications or expected standards.
Perform daily instrument calibrations and verifications as required.
Conduct cGMP analytical data reviews to ensure compliance with established procedures, analytical standards, GVLs, and SOPs.
Ensure laboratory testing and activities comply with regulations, ICH guidelines, USP/EP Pharmacopeia, GMP, and data integrity requirements.
Potentially author or review OOS investigations, deviations, change controls, technical reports, protocols, validation summaries, SOPs, and specification documents.
Meet job-related safety training and compliance requirements.
Potentially assist with training as a subject-matter expert.
Communicate project status and concerns to project leads and management.
Set project priorities and manage time to maximize productivity.
Participate in ongoing training and seek opportunities to develop skills and responsibilities.
Potentially run projects at the broad-task level under supervision, ensuring deliverables are met and next steps are identified.
Participate in client meetings and teleconferences.
Perform duties in compliance with SOPs, GMP, GLP, and safety guidelines, and maintain the compliance status required by company and facility standards.