MS&T Specialist

Teva Pharmaceuticals•Whitchurch-Stouffville, ON

About The Position

Teva Canada is currently seeking a MS&T Specialist to join our team. Reporting to Director MS&T, the MS&T Specialist is responsible for planning, scheduling, co-ordination and tracking the group's work activities.

Requirements

Bachelor of Science degree in pharmacy, chemical engineering or a related science; Master Degree in Science degree in pharmacy, chemical engineering or a related is preferred
7+ years of experience in drug development or scale-up, technology transfer of solids, and controller release dosage forms.
Minimum five (5) to seven (7) years' experience in formulation development/process development, technology transfer, process validation and/or production of solids and 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 is essential.
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.

Nice To Haves

Master Degree in Science degree in pharmacy, chemical engineering or a related is preferred

Responsibilities

Lead or support transfer of processes from R&D/other commercial site to commercial sites at Teva Canada.
Prepare and review technology transfer protocols, reports, batch records, and risk assessments.
Coordinate process scale-up activities and engineering/validation batches.
Ensure to participate and implementation of knowledge transfer between sending and receiving sites.
Work closely with Production, QA, QC, Validation, Regulatory Affairs, Engineering, and Supply Chain teams.
Coach staff through the provision of regular feedback in the form of status meetings, objective setting sessions, performance appraisals, counseling, discipline and the assignment of projects. Manage the activities of all indirect reports to ensure timely and effective completion of projects and tasks.
Provide guidance and coaching to the other members of the Technical Services Group.
Effective root cause analysis to determine cause for failure results. Review, challenge and execute preferred process to improve the process to cost savings or reduce deviations or cycle time.
Work independently with responsibility to accommodate frequently changing and urgent priorities.
Coordinate general knowledge on investigations and changing regulatory and/or global requirements within the Technical Services for the continuous improvement of investigation quality and compliance.
Evaluate and report on investigation trends and CAPAs implemented by the QA.
Act as a resource person to team staff, management and internal customers with respect to project status and information flow.
Serve in a supervisory capacity and communicates department's objectives. Participate in developing action plans for the improvement of the org. unit.
Ensure that all advice given to the specifications group team members as well as internal/external contacts and highly complex decisions made at this level are compliant with regulations governing their work.
Attend the Technical Review meetings and update status reports of activities for rework, conversion projects, alternate suppliers, international submissions and scale-up etc.
Review and approve change controls/batch records in timely manner.
Participate in product improvement, process design, and validation meetings as a means to move projects forward.
Responsible for the manufacture of submission batches related to alternate raw material suppliers for Canadian, EU and U.S. Markets (exhibition and CBE batches).
Assist Regulatory Affairs Department for filing & submission requirements.
Initiate, participate, supervise, oversee and successfully complete Process Improvements, Cycle Time Reduction, Cost Reduction, and Scale up, Alternate API qualification, Technology transfer & Submission projects and meet the deadlines.
Participate in re-design/ re-formulate existing products to maximize efficiency, capacity and quality.