Posted 14 days ago
Scientist II, Development Operations
AI Summary
Scientus II in Development Operations prepares analytical method validation protocols and reports, performs HPLC, GC, dissolution and physical testing, and ensures compliance with GMP, GLP, ICH, and FDA standards in a pharmaceutical laboratory.
About this role
Work Schedule
Flex Shifts 40 hrs/wkEnvironmental Conditions
Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materialsJob 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.
Summary:
Assist with preparation ofanalytical method validation protocols and reports, method transfer protocols and reports, analytical methods, and specifications used by the Development Laboratory ensuring they meet current regulatory, corporate and industry standards. Performbench workto support client projects.
Essential Functions:
Assist with preparation oftechnical documents such as method validation and transfer protocols, reports, analytical methods, and specifications.
Help to provide input on generation ofmethod transfer plans for incoming projects.
Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
Independently carryout HPLC, dissolution, GCand physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs).
Work Proficiency with Empower, NuGenesis, MS Word & Excel Software.
Recognize and report unexpected or OutOfSpecification (OOS) results immediately to the Supervisor and conduct laboratory investigations under direction.
Maintain a safe working environment and report potential hazards.
Perform alternating or rotating shift work (as required)
REQUIRED QUALIFICATIONS
Education:
Bachelor of Science (B.Sc.) in Chemistry or related science
Experience:
Minimum3years’pharmaceutical laboratory work experience
Experience in preparation of technicaldocuments
Experience in laboratory testing and method validation
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered
Knowledge, Skills,and Abilities:
Strongknowledge of analytical method validation requirements.Excellent Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge.Knowledge of regulatory requirements including USP/NF and Ph. Eur.Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint, Chemstation and OpenLab. Well organized and detail oriented. Excellentinterpersonal and communication skills (both oral and written). Ability to work well independently and in a team environment with limited supervision. Ability to prioritize multiple tasks. Proficient with the English language.
Compensation
The estimated annualized pay range for this position in Ontario is $62,000.00–$93,000.00.Skills
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