Job Title

**Work Schedule** Standard Office Hours (40/wk) **Environmental Conditions** Laboratory Setting **Job Description** As part of the Thermo Fisher Scientific team, youu2019ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worldu2019s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Summary: Supervise the activities of the Development Operations group within Laboratory Operations. Ensure all activities are in accordance with Standard Operating Procedures (SOP), current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), Corporate Quality Standards and client objectives/timelines are achieved. Essential Functions: u00b7 Supervise a Team of 7-10 Scientists responsible for the execution of analytical method development, evaluation, validation, transfer and verification; excipient compatibility studies (ECS) and forced degradation (FD) studies in support of client projects. u00b7 Ensure cGMP and Environmental Health & Safety compliance as well as good laboratory housekeeping and documentation practices of direct reports. u00b7 Conduct weekly direct report huddles to facilitate problem solving and communication. Maintain accountability of the team with regards to standard work, compliance, scientific integrity, documentation and project execution. u00b7 Ensure that all Development Operation (DO) laboratory documentation within the group is completed to the highest quality standards, in compliance with Attributable Legible Contemporaneous Original and Accurate (ALCOA). u00b7 Design and monitor progress against the schedules for each direct report in the group to ensure studies are completed in accordance with project timelines, On Time Delivery (OTD) dates and client expectations. u00b7 Support the creation and completion of Stability PDS Certificate of Analysis (CofA) and batch CofA release for feasibility, prototype and clinical trial as well as for Registration batch studies. u00b7 Supports development of test methods and their respective validation along with review of the protocols/reports. u00b7 Support execution of method transfers/verifications for Analytical Development team. u00b7 Support the method training of Analytical Operations team when products and test methods move from development to commercial testing. u00b7 Support development and execution of PDS Stability protocols and their respective reports along with SAR (LIMS Stability Analytical reports) approval. u00b7 Support the execution of PDS laboratory-related quality events (OOS/URu2019s, DRu2019s, CAPAu2019s, ECu2019s) to drive on time and scientifically sound closures.as well as approval of the Lab Incident Records. u00b7 Ensure External Lab test results are received in a timely manner. u00b7 Engage with clients and Business/Project Managers to provide updates to timelines and remove roadblocks to meet timelines. u00b7 Supervise the training of all analysts within the group to ensure they are fully competent to conduct the studies assigned to them and that they are provided with a career development plan. u00b7 Ensure professional development of self and staff by keeping up to date with advances in pharmaceutical and regulatory developments. u00b7 Support, develop and implement departmental continuous improvement PPI initiatives. u00b7 Make recommendations to the Manager for additional personnel and equipment resources that might be needed to meet our project commitments and any other continued improvements. u00b7 Maintain excellent communications with DO Lab Manager and Technical Leads to ensure awareness of any deviations of required performance standards. u00b7 Ensure the Manager is provided with a weekly recap for departmental awareness u00b7 Participate in goal setting and conduct performance reviews for direct reports. u00b7 Support actions needed to initiate and/or approve Trackwise change control execution for any Lab Operation changes. u00b7 Drive staff development, recruitment and performance management u00b7 Promote and maintain a safe working environment, report potential hazards, and ensure all direct reports follow Environmental Health and Safety procedures. u00b7 Select, develop, and evaluate colleagues to ensure the efficient operation of the function. Work with and advise colleagues on administrative policies and procedures. Physical Requirements: Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Use of Personal Protective equipment may be required and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally. A/QPIC / A/RPIC Summary (if applicable): The A/QPIC / A/RPIC will act on behalf of the QPIC / RPIC during times of absence with respect to performing QPIC / RPIC Essential Functions. A/QPIC / A/RPIC is responsible for following the Office of Controlled Substances (OCS) regulations and Company Standard Operating Procedures (SOPu2019s) for the management of Narcotics and Controlled Drug Substances, and the Precursor Control Regulations and Company SOPu2019s for the management of Class A Precursors. Essential Functions: u00a7 Issue and return Narcotic & Controlled Drug Substances and Class u201cAu201d Precursor materials from their secure zones (approved licensed storage locations) to facilitate the timely execution of processing, packaging and shipping activity. u00a7 Secure Narcotics & Controlled Drug Substances rejects, and Class u201cAu201d Precursor rejects and maintain monthly inventory. u00a7 Manage and witness Narcotic & Controlled Drug Substances destruction. u00a7 Manage the Class u201cAu201d Precursor destruction process. u00a7 Complete log entries as per procedural requirements and maintain records to facilitate monthly and annual reports. u00a7 Process Narcotics & Controlled Drug Substances and Class u201cAu201d Precursor samples u00a7 Maintains excise records for alcohol usage and prepares monthly returns. u00a7 Maintains Narcotic data-base & reconciles it with log sheets in all 5 locations of Narcotics and controlled substances. u00a7 Co-ordinates with OCS, RCA & Health Canada on all outstanding observations to remain in compliance. u00a7 Performs Annual Inventory of Class u201cAu201d Precursors by physical count and submits report to Health Canada u00a7 Completes report tracker on a monthly basis to make sure that all reports required to be sent to RCA, HC, OCS, etc. are prepared and delivered on time u00a7 Facilitates in import / export permits for Narcotics & Controlled Drug Substances and Class u201cAu201d Precursors. u00a7 Maintains Narcotics & Controlled Drug Substances locations within illicit value limits assigned by Health Canada. u00a7 Completes a comprehensive screening (per applicable regulations) to ensure no prior history of relevant criminal offences related to Controlled Substance Policy (CSPPs), denial for application for registration to handle CSPP, or revocation or surrender-for-cause of registration to handle CSPPs. u00a7 Completes annual criminal background check as part of QARA-P0007, Narcotics Policy and POL- u2013 PSG Controlled Substance Policy u00a7 Participates in random employee searches as part of Anti-Theft/Employee Assigned Company Property Inspection Policy (Mississauga and Whitby, PSG) CAN-HR-Policy-370 u00a7 Participates in random drug testing as part of QARA-P0007, Narcotics Policy and POL- u2013 PSG Controlled Substance Policy - not applicable to Canadian employees. u00a7 Maintain Narcotics & Controlled Substances and Class A Precursor procedures to ensure alignment to corporate policies and regulations u00a7 Manage Narcotics & Controlled Substances and Class A Precursor Regulatory, Corporate, and Internal Audits u00a7 Collaborate with auditors and represent the site as required during inspections to ensure information is provided in a timely, accurate and complete manner. u00a7 Maintain awareness of regulatory intelligence in support of gap identification and mitigation to ensure compliance. u00a7 Provide ongoing coaching and mentoring to site A/QPICs and A/RPICs to ensure compliance to requirements across the site. u00a7 Responsible to ensure the designated A/QPIC is trained to assume QPIC responsibilities for Narcotics & Controlled Drug Substances when the QPIC is absent or unavailable. u00a7 Responsible to ensure the designated A/RPIC is trained to assume RPIC responsibilities for Class u201cAu201d Precursors when the RPIC is absent or unavailable. REQUIRED QUALIFICATIONS Education: Minimum Bachelor of Science (B.Sc.) in organic chemistry, analytical chemistry or a related science Experience: Minimum 5 yearsu2019 previous pharmaceutical analytical laboratory setting experience Minimum of 3 yearsu2019 previous supervisory experience. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. **Compensation** The salary range estimated for this position based in Ontario is $84,900.00u2013$112,000.00. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.