Thermo Fisher Scientific
Develop new formulations, processes, and scale-up procedures of strong and semi-solid dosage kinds on the pre-clinical, medical, scale up, registration and validation levels of drug improvement. Coordinate Pharmaceutics and Course of Expertise (PPT) venture 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 improvement reviews.
- Take part in or lead downside fixing for formulations, gear, and processes.
- Write protocols and manufacturing playing cards for feasibility and medical trial supplies.
- Write and guarantee well timed execution of protocols and provision of leads to accordance with present Good Manufacturing Practices (GMPs) and firm requirements.
- Current interpreted outcomes and updates to Enterprise Improvement, Consumer Companies, Pharmaceutical Improvement Companies (PDS), Operations, and particular person shoppers.
- Keep a secure working setting and report potential hazards.
- Carry out alternating or rotating shift work (as required)
Bachelor of Science (B.Sc.) in pharmaceutical science or know-how.
Minimal 3 years of pharmaceutical formulation/know-how expertise.
Equal mixtures of schooling, coaching, and related work expertise could also be thought of.
Data, Abilities 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 information. Capable of carry out job necessities whereas carrying Private Protecting Tools (PPE) -Powered Air Purifying Respirator (PAPR), Tyvek go well with and double gloves. Capability to speak and liaise with consumer and different departments. Good organizational, documentation and housekeeping expertise. Capability to work effectively independently and in a staff setting with restricted supervision. Wonderful written and oral communication expertise. Communicates and co-operates with others to satisfy venture and staff 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 staff members, modelling constructive staff ideas and partnering to satisfy venture and departmental goals. Perform all duties inside strict compliance to Patheon high quality programs SOP’s and Good Manufacturing Observe (GMP). Keep workspace in a clear and orderly trend. Actively have interaction in and cling to departmental programs with a view to preserve a clean and environment friendly workflow (visible administration, scheduling programs, and so on.). Be consumer and affected person aware always. Perceive Key Efficiency Indicators and attempt to enhance the efficiency of the staff by figuring out areas for system enhancements and have interaction in downside fixing. Fashions constructive pondering and is open to alter, motivating the staff 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. Persistently strives to enhance expertise and information in associated subject.
Place requires atypical ambulatory expertise and bodily coordination ample to maneuver about lab/lab workplace places; skill to face, stroll, stoop, kneel, crouch periodically for extended durations of time; manipulation (elevate, carry, transfer) of sunshine to medium weights of 10-35 kilos; arm, hand and finger dexterity, together with skill to understand and kind for extended durations of time; visible acuity to make use of a keyboard, laptop monitor, function gear, and skim supplies for extended durations of time; skill to sit down, attain with fingers and arms, discuss, and listen to for extended durations of time. Use of Private Protecting gear could also be required and will embrace any of the next: Security glasses, security footwear, lab coat, latex or comparable gloves, security apron, natural respirator sometimes.
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