Responsibilities:

• Provide coaching, guidance to team members to ensure timely and effective completion of projects and tasks.
• Present regular feedback to staff through status meetings, objective setting sessions, performance appraisals, counselling, discipline, and project assignments.
• Conduct root cause analysis to determine the cause of failures, then review results and recommend solutions to improve processes and reduce deviations or cycle time.
• Keep up to date with regulatory requirements and share general knowledge with the Technical Services group to improve investigation quality and compliance.
• Work independently with responsibility to accommodate frequently changing and urgent priorities.
• Act as a resource person to team staff, management, and internal customers regarding project status and information flow.
• Serve in a supervisory capacity and communicate department objectives, as well as participating in developing action plans to improve the organizational unit.
• Ensure that all advice given to the specifications group team members and internal/external contacts, as well as all highly complex decisions made at this level, are compliant with regulations governing the work.
• Attend Technical Review meetings, update status reports, review and approve change controls/batch records, and participate in product improvement, process design, and validation meetings.
• Participate in product improvement, process design, and validation meetings as a means to move projects forward.
• Initiate, participate in, supervise, oversee, and successfully complete Process Improvements, Cycle Time Reduction, Cost Reduction, Scale-up, Alternate API qualification, Technology transfer and Submission projects, and ensure deadlines are met.
• Participate in re-design/re-formulate existing products to maximize efficiency, capacity, and quality. 

Qualifications:

• Bachelor's or Master's Degree in Pharmacy, Chemical Engineering, or a related science.
• 5-7+ years of experience in drug development, formulation development, production of solids, controlled release dosage forms.
• Demonstrated expertise in product development, process development, process validation, and GMP.
• Sound knowledge of ICH, Canadian and U.S. regulatory guidelines and quality assurance.
• Excellent command of the English language, both verbal and written.
• Highly organized and capable of handling multiple technical projects concurrently within a cross-functional team environment.
• Self-starter who can work with minimal supervision with strong leadership skills.