Thermo Fisher Scientific
Develop new formulations, processes, and scale-up procedures of strong and semi-solid dosage kinds on the pre-clinical, scientific, scale up, registration and validation phases of drug growth. Coordinate Pharmaceutics and Course of Expertise (PPT) undertaking actions.
- Carry out manufacturing actions together with set-up, operating and cleansing of apparatus and rooms.
- Take part in or lead the design/analysis of formulations and manufacturing processes for strong, semi-solid, or liquid dosage kinds.
- Write growth studies.
- Take part in or lead drawback fixing for formulations, tools, and processes.
- Write protocols and manufacturing playing cards for feasibility and scientific trial supplies.
- Write and guarantee well timed execution of protocols and provision of ends in accordance with present Good Manufacturing Practices (GMPs) and firm requirements.
- Current interpreted outcomes and updates to Enterprise Growth, Shopper Providers, Pharmaceutical Growth Providers (PDS), Operations, and particular person purchasers.
- Preserve a secure working atmosphere and report potential hazards.
- Carry out alternating or rotating shift work (as required)
Bachelor of Science (B.Sc.) in pharmaceutical science or expertise.
Minimal 3 years of pharmaceutical formulation/expertise expertise.
Equal mixtures of schooling, coaching, and related work expertise could also be thought of.
Information, Expertise and Skills:
Demonstrated understanding of apparatus, formulations and processes. Good understanding of Good Manufacturing Practices, Customary Working Procedures and United States Meals and Drug Administration (FDA) compliance data. Capable of carry out job necessities whereas sporting Private Protecting Tools (PPE) -Powered Air Purifying Respirator (PAPR), Tyvek go well with and double gloves. Skill to speak and liaise with consumer and different departments. Good organizational, documentation and housekeeping expertise. Skill to work properly independently and in a workforce atmosphere with restricted supervision. Glorious written and oral communication expertise. Communicates and co-operates with others to fulfill undertaking and workforce goals. Demonstrated laptop proficiency with Microsoft Workplace applications. Proficiency with the English Language.
Requirements and Expectations:
Observe all Environmental Well being & Security Insurance policies and Procedures. Work collaboratively with fellow workforce members, modelling optimistic workforce ideas and partnering to fulfill undertaking and departmental goals. Perform all duties inside strict compliance to Patheon high quality techniques SOP’s and Good Manufacturing Apply (GMP). Preserve workspace in a clear and orderly style. Actively have interaction in and cling to departmental techniques to be able to preserve a clean and environment friendly workflow (visible administration, scheduling techniques, and many others.). Be consumer and affected person acutely aware always. Perceive Key Efficiency Indicators and attempt to enhance the efficiency of the workforce by figuring out areas for system enhancements and have interaction in drawback fixing. Fashions optimistic pondering and is open to vary, motivating the workforce to adapt to shifts in priorities and new methods of working. Proactively establish areas for enchancment within the execution of procedures. Talk dangers to timelines in a proactive method. Constantly strives to enhance expertise and data in associated subject.
Place requires extraordinary ambulatory expertise and bodily coordination ample to maneuver about lab/lab workplace places; potential to face, stroll, stoop, kneel, crouch periodically for extended intervals of time; manipulation (carry, carry, transfer) of sunshine to medium weights of 10-35 kilos; arm, hand and finger dexterity, together with potential to understand and kind for extended intervals of time; visible acuity to make use of a keyboard, laptop monitor, function tools, and browse supplies for extended intervals of time; potential to sit down, attain with arms and arms, discuss, and listen to for extended intervals of time. Use of Private Protecting tools could also be required and will embody any of the next: Security glasses, security footwear, lab coat, latex or comparable gloves, security apron, natural respirator often.
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