Data Reviewer - Analytical RD

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Fluctuating Temps hot/cold, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Provides review of data collected by the Analytical R&D department. Provides technical assessment of the data and documents. Ensures that all data has been collected in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMP) and corporate quality standards. Data will be related to testing and method development/validation for raw materials, production intermediates, and final products on highly unique and complex projects. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development.

Essential Functions:

Liaises with Analytical R&D scientists to discuss the data, documentation, and analytical documents (methods, protocols, reports). Must have strong technical knowledge of HPLC, GC, KF, FTIR, and NMR. 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. Performs other duties as assigned.

Education:

BS in Chemistry or commensurate experience required

Experience:

Requires 10 years of progressive scientific experience in an analytical laboratory environment, including hands-on experience with HPLC, GC, KF, and FTIR.

Competencies:

• Technical excellence in the understanding and application of analytical chemistry.
• Excellent interpersonal and communication skills.
• Well organized, detail oriented and able to prioritize multiple tasks.
• Experience with Microsoft Word and Excel
• Understanding of Analytical R&D software systems, such as Empower, that are being applied within modern pharmaceutical companies
• Excellent working knowledge of Good Manufacturing Practices
• Proficiency in the English Language.
• Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically; 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.