Technical Project Manager
5 days ago
We are seeking a highly skilled and experienced Technical Project Manager to lead the design and evaluation of formulations and manufacturing processes for solid, semi-solid, or liquid dosage forms. The successful candidate will have a strong background in pharmaceutical development and a proven track record of managing projects and teams.
Key Responsibilities- Lead the design/evaluation of formulations and manufacturing processes for solid, semi-solid, or liquid dosage forms.
- Develop 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 the Pharmaceutics and Process Technology (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 advise staff on administrative policies and procedures.
- Perform alternating or rotating shift work (as required).
- Bachelor of Science 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.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- 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.
The successful candidate will be required to work in a comfortable indoor area with occasional exposure to mild physical discomfort from factors such as dust, fumes, or odors, 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 occasion.
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