Scientist Ii

6 months ago

Mississauga, Canada Thermo Fisher Scientific Full time

**Summary**:
Develop new formulations, processes, and scale-up procedures of solid and semi-solid dosage forms at the pre-clinical, clinical, scale up, registration and validation stages of drug development. Coordinate Pharmaceutics and Process Technology (PPT) project activities.

**Essential Functions**:

- Perform manufacturing activities including set-up, running and cleaning of equipment and rooms.
- Participate in or lead the design/evaluation of formulations and manufacturing processes for solid, semi-solid, or liquid dosage forms.
- Write development reports.
- Participate in or lead problem solving for formulations, equipment, and processes.
- Write protocols and manufacturing cards for feasibility and clinical trial materials.
- Write and ensure timely execution of protocols and provision of results in accordance with current Good Manufacturing Practices (GMPs) and company standards.
- Present interpreted results and updates to Business Development, Client Services, Pharmaceutical Development Services (PDS), Operations, and individual clients.
- 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 pharmaceutical science or technology.

**Experience**:
Minimum 3 years of pharmaceutical formulation/technology experience.

**Equivalency**:
Equivalent combinations of education, training, and relevant work experience may be considered.

**Knowledge, Skills and Abilities**:
Demonstrated understanding of equipment, formulations and processes. Good understanding of Good Manufacturing Practices, Standard Operating Procedures and United States Food and Drug Administration (FDA) compliance knowledge. Able to perform job requirements while wearing Personal Protective Equipment (PPE) -Powered Air Purifying Respirator (PAPR), Tyvek suit and double gloves. Ability to communicate and liaise with client and other departments. Good organizational, documentation and housekeeping skills. Ability to work well independently and in a team environment with limited supervision. Excellent written and oral communication skills. Communicates and co-operates with others to meet project and team objectives. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

**Standards and Expectations**:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

**Physical Requirements**:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab 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 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. Use of Personal Protective equipment may be required and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

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