Technical Project Leader I - PPT
$76,400–$95,000 year
On-siteWhitby, Ontario, Canada
Job Summary
Lead the design and evaluation of formulations and manufacturing processes for solid, semi-solid, or liquid dosage forms across pre-clinical, clinical, and post-marketing stages. Manage resources in the Pharmaceutics and Process Technology work group to achieve project objectives, including tech transfer of clinical and registration batches. Write protocols for feasibility work, manufacturing batch records, and clinical trial materials while ensuring adherence to Good Manufacturing Practices and FDA compliance. Liaise with Project Management, Facility Schedulers, and other functional areas to meet team goals. Coach associates in technical matters and drug development systems, select staff, and promote a safe working environment by reporting hazards and enforcing safety standards. Perform alternating or rotating shift work as required.
Required Qualifications
- Bachelor of Science (B.Sc.) in pharmaceutical science or technology
- Minimum 4 years of previous related experience
- general knowledge of drug development
- Previous Project Management experience
- Previous Supervision and/or leadership experience
- Equivalent combinations of education, training, and relevant work experience
- 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 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
- 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
- Perform alternating or rotating shift work (as required)
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
- 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)
Desired Qualifications
- Previous Supervision and/or leadership experience an asset
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