Thermo Fisher Scientific Scientist 3 (Technical Writer) in St. Louis, Missouri
Prepare new documents as per ICH guidelines for Biopharmaceutical Drug Substance such as specs, Qualification plans/reports, Validation/Verification protocols/reports, and Method Transfer protocol/reports. Revises and updates standard operating procedures and test methods as needed.
Authors, reviews qualification, validation, method transfer documents.
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
Complies with all company and site policies and procedures. Reports any non-conformances. Initiates and/or leads resolution efforts and laboratory investigations.
Trains junior level staff in analytical method transfer.
Effective oral and written communication skills.
Working knowledge of cGMPs and Quality Control regulatory requirements
Experience with authoring documents for qualification/validation of QC assays.
Performs analytical and technical troubleshooting
Bachelor’s Degree in a Science related field; will consider Associate's degree with considerable more years of experience in a biopharmaceutical lab environment
5+ years of experience in method validation and method qualification.
Prior experience authoring documents for qualification/validation of QC assays
Experience performing analytical and technical troubleshooting
Prior experience in a GMP environment highly preferred with a working knowledge of cGMPs and Quality Control regulatory requirements.
Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred.
ELISA experience with large molecules is strongly preferred.
Routine use of MS Excel, MS PowerPoint, and MS Word is essential
- Equivalent combinations of education, training, and relevant work experience may be considered.
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.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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