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 using defined procedures and practices. The role conducts moderately sophisticated analytical testing on 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 detailed observations, review and documentation of results, and clear communication of test outcomes. The position develops, evaluates, validates, and transfers analytical methods; tests pharmaceutical raw materials and finished products; reviews cGMP analytical data; and supports compliance with regulations, ICH guidelines, USP/EP Pharmacopeia, GMP, data-integrity requirements, and established procedures. The scientist may prepare or review investigations, change-control and deviation documentation, reports, protocols, validation summaries, SOPs, and specifications. The role may also contribute to training, client meetings, and supervised project execution.

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 implement 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 stand, walk, stoop, kneel, and crouch periodically for prolonged periods.
Ability to lift, carry, or move light-to-medium weights of 10–35 pounds.
Arm, hand, and finger dexterity, including grasping and typing for prolonged periods.
Visual acuity for keyboard and monitor use, equipment operation, and reading materials for prolonged periods.
Ability to sit, reach with hands and arms, talk, and hear for prolonged periods.

Nice To Haves

At least 1 year of related pharmaceutical industry experience with a master's degree is strongly preferred.
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 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 results, unexpected results, and non-routine analytical or product problems.
Determine whether reported data meet specifications or expected standards.
Perform daily instrument calibrations and verifications as required.
Conduct cGMP analytical data review across techniques to ensure adherence to procedures, analytical standards, GVLs, and SOPs.
Ensure laboratory testing and activities comply with regulations, ICH guidelines, USP/EP Pharmacopeia, GMP, and data-integrity requirements.
Possibly 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.
Possibly 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.
Possibly run projects at the broad-task level under supervision, ensuring deliverables are met and next steps are identified.
Participate in meetings and teleconferences with clients.
Perform duties in compliance with SOPs, GMP, GLP, and safety guidelines, and maintain the compliance status required by company and facility standards.