Scientist III, Analytical R&D

Work Schedule

Environmental Conditions

Job Description

The Scientist III will develop, investigate, create, transfer, and validate new scientific methodologies used to analyze raw materials, production intermediates, and final products. Conduct laboratory work as needed to assure that products are tested per operating procedures. Ensure that work is carried out in an efficient and safe manner. Support internal development and/or manufacturing operations. Make detailed observations and reviews, documents, and communicate test results internally and externally to clients. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development. Works on significant technical/scientific project activities to implement strategies and technical solutions that meet client needs and expectations. Participate in technical discussions with clients. Assist in the design of methods and support problem solving as needed with leadership and independent judgment. Make decisions that frequently require developing new options to solve problems.

• Develop feasible QC-friendly analytical methods for drug intermediates and APIs that meet or exceed the quality requirements from clients.

• Collect reliable data through designed laboratory experiments with accurate, detailed documentation for evaluation, development and troubleshooting.

• Record and analyze scientific data/observations in detail. Summarize and interpret data to draw logical conclusions. Write technical updates/reports. Participate in technical discussions with internal teams and clients.

• Draft, Review Methods, Protocol, Reports, Deviations, Change Controls, and Investigative documentation.

• Complete procedures under SOP/cGMP guidelines.

• Evaluate technical package and successfully lead analytical technology transfer.

• Provide timely technical support for Process R&D, Quality Control and other inter-departmental needs.

• Lead projects with minimal supervision; may lead projects, including but not limited to managing process development timelines and deliverables, coordinating analytical development activities.

• Perform developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing, and trains other employees on these techniques.

• Provide thoughtful technical review of data collected by other employees.

• Investigate out-of-specification or unexpected results and non-routine analytical and product problems.

• Communicate results of work by crafting documentation of the testing/analysis and obtained results. Record and report results of analysis in accordance with prescribed lab procedures and systems.

• Ability to drive functional, technical and operational excellence. Ability to inspire and drive team effectiveness. Good knowledge of medical terminology, clinical data, and Good Manufacturing Practices (GMP).

• Masters degree in chemistry or related field required; equivalent combinations of education, training, and relevant work experience may be considered.

• 10+ years of experience in a laboratory preferred, (GLP or GMP/cGMP environment preferred)

• 10+ years of experience with analytical instrumentation, such as HPLC, GC, and LCMS.

• Analytical knowledge across many techniques is required including at least NMR, IR, KF, HPLC, GC, and MS.

• Knowledge and understanding of chemistry and analytical instrumental technologies.

• Knowledge of qualitative and quantitative chemical analysis.

• Extensive knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Understand and work in compliance with all cGMP, OSHA, and safety regulations, BOPs and SOPs.

• Good interpersonal and communication skills (both oral and written). Good presentation skills to present information and respond to inquiries to customers, clients, regulatory agencies and colleagues.

• Ability to read, analyze, and interpret technical procedures and governmental regulations.

• Ability to write standard operating procedures, simple protocols, and reports.

• 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.