Scientist II – PPT

Thermo Fisher Scientific

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Job Description

Abstract:

Develop new formulations, processes, and scale-up procedures of strong and semi-solid dosage types on the pre-clinical, medical, scale up, registration and validation levels of drug growth. Coordinate Pharmaceutics and Course of Expertise (PPT) mission actions.

Important Capabilities: 

  • Carry out manufacturing actions together with set-up, working and cleansing of kit and rooms.
  • Take part in or lead the design/analysis of formulations and manufacturing processes for strong, semi-solid, or liquid dosage types.
  • Write growth stories.
  • 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 ends in accordance with present Good Manufacturing Practices (GMPs) and firm requirements.
  • Current interpreted outcomes and updates to Enterprise Growth, Consumer Companies, Pharmaceutical Growth Companies (PDS), Operations, and particular person purchasers.
  • Keep a protected working surroundings and report potential hazards.
  • Carry out alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS

Training:

Bachelor of Science (B.Sc.) in pharmaceutical science or expertise.

Expertise:

Minimal 3 years of pharmaceutical formulation/expertise expertise.

Equivalency:

Equal mixtures of training, coaching, and related work expertise could also be thought of.

Information, Expertise and Skills:

Demonstrated understanding of kit, formulations and processes. Good understanding of Good Manufacturing Practices, Normal Working Procedures and United States Meals and Drug Administration (FDA) compliance information. Capable of carry out job necessities whereas sporting Private Protecting Gear (PPE) -Powered Air Purifying Respirator (PAPR), Tyvek go well with and double gloves. Means to speak and liaise with consumer and different departments. Good organizational, documentation and housekeeping abilities. Means to work nicely independently and in a workforce surroundings with restricted supervision. Wonderful written and oral communication abilities. Communicates and co-operates with others to satisfy mission and workforce goals. Demonstrated laptop proficiency with Microsoft Workplace packages. 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 constructive workforce ideas and partnering to satisfy mission and departmental goals. Perform all duties inside strict compliance to Patheon high quality methods SOP’s and Good Manufacturing Follow (GMP). Keep workspace in a clear and orderly style. Actively have interaction in and cling to departmental methods with a purpose to keep a easy and environment friendly workflow (visible administration, scheduling methods, 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 downside fixing. Fashions constructive considering and is open to alter, 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. Persistently strives to enhance abilities and information in associated subject. 

Bodily Necessities:

Place requires unusual ambulatory abilities and bodily coordination adequate 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 arms and arms, speak, and listen to for extended durations of time. Use of Private Protecting gear 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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