Technical Project Leader I - PPT

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job 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. Lead the design and evaluation of formulations and manufacturing processes as well as problem solves for solid, semi-solid, or liquid dosage forms.  Engage in the management of clientele, processes, and equipment design for clinical, scale up, and registration batches including tech transfer of projects to and from clients. Manage resources in the Pharmaceutics and Process Technology (PPT) work group to achieve project and team objectives and coach associates in their work group in areas such as the drug development process and Pharmaceutical Development Services (PDS) systems.  Liaise with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives. Essential Functions:  Lead the design/evaluation of formulations and manufacturing processes for solid, semi-solid, or liquid dosage forms.  Lead development of new formulations and scale-up procedures of solid, semi-solid, or liquid dosage forms at the pre-clinical, clinical, and post marketing stages of drug development. Manage resources in their PPT work group to achieve project and team objectives. Lead/participate in problem solving for formulations, equipment and processes. Participate in relevant meetings/teleconferences with clients. Write protocols for feasibility work and manufacturing batch records and clinical trial materials.  Write and ensure timely execution of protocols and provision of results in accordance with current Good Manufacturing Practices and company standards. Write development reports. Develop realistic proposals and timelines. Liaise with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives. Coach others in technical matters and systems relating to the PPT. Promote a safe working environment, report potential hazards and ensure all direct reports follow Environmental Health and Safety procedures. Select, develop (goal setting) and evaluate staff to ensure the efficient operation of the function. Work with and advises staff on administrative policies and procedures (if applicable). Perform alternating or rotating shift work (as required).

Education: Bachelor of Science (B.Sc.) in pharmaceutical science or technology.

Minimum 4 years of previous related experience and general knowledge of drug development. Previous Project Management experience. Previous Supervision and/or leadership experience an asset. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Abilities: Strong knowledge and understanding of the drug development process.  Demonstrated understanding of equipment, formulations and processes.  Good Manufacturing Practices, Standard Operating Procedures and Food and Drug Administration (FDA) compliance knowledge. Demonstrable organizational skills relevant to drug development.  Ability