Technical Project Leader II

at  Thermo Fisher Scientific

SUMMARY:

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.

EDUCATION:

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

EXPERIENCE:

Minimum 6 years of experience 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:
Extensive knowledge and understanding of the drug development process. Demonstrated understanding of equipment, formulations and processes. Excellent Good Manufacturing Practices, Standard Operating Procedures and Food and Drug Administration (FDA) compliance knowledge. Established leadership skills. Demonstrable organizational skills relevant to drug development. Excellent written and oral communication skills. Ability to communicate and liaise with clients 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. Ability to meet deadlines and prioritize multiple project deliverables. The ability to motivate and influence. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.

PHYSICAL REQUIREMENTS:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

• 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.
• Coach associates in their work group in areas such as the drug development process and PDS systems.
• Liaise with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives.
• Maintain expert knowledge of pharmaceutical processes, equipment, instrumentation and procedures necessary to perform the tasks.
• Keep current with scientific literature and industry trends relating to process technologies; disseminate relevant information.
• As the key technical leadership role in Centre of Excellence Initiative; look for opportunities for publication/external presentations.
• 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).