Position is onsite and will sit/work at the Whitby, Canada site and will support the Drug Product Division at Thermo Fisher Scientific.

Supervise the activities of an Analytical Operations (AO) Group, within Laboratory Operations, ensuring that all Standard Operating Procedures (SOP), current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), CorporateQualityStandardsand client objectives/timelines are achieved.

Supervise a Team of10-14Scientists whoare responsible forthe execution of product evaluation/CofArelease andcommercial Stability testing in support of client projectsand timelines.

• Ensure cGMP and Environmental Health & Safety compliance, as well as good laboratory housekeepingand documentationpracticesofdirect reports.

• Provide technical leadership for analytical challenges.

• Conductweeklydirect reportteam huddlesin order tofacilitateproblem solving and communication. Maintain accountability of the teamforstandard work, compliance, scientific integrity,documentationand project execution.

• Convey results of analytical studies to colleagues and clients and provide scientific input with regards to unexpected results, overall productstabilityand formulation development efforts.

• Ensure that all AO laboratory documentation within the groupiscompleted to the highest quality standards, in compliance with Attributable Legible Contemporaneous Original and Accurate (ALCOA) and documented Right-First-Time(RFT).

• Ensure all testing (i.e.raw material, finished product, in-process, intermediate, micro, purified water)is completedin accordancewithapproved test methods andSOPs.

• Ensureall LIMS Certificate of Analysis (CofA); Analytical ReleaseForm(ARF) and Control Procedure (CP) are current andaccurate.

• Ensure Follow-Up Stability Testing (FUST) and any other commercial Stability study testingare completed on timeto avoid deviations.

• Ensure customer complaints are supported as needed.

• Ensurecommercial product Out-Of-Specification (OOS) or Unexpected/Out-Of-Trend (OOT) investigations are supported for phase 1 lab testingand approval of the Lab Incident Records.

• Ensure External Lab test results are receivedin a timely mannerincluding any results received from Patheon-Toronto Regional Operations (TRO)

• Design andmonitorprogress against the schedules for each Scientist in thegroup. Ensure that studies are completedin accordance withproject timelines, On Time Delivery (OTD)datesand client expectations.

• Supervise the training of allScientistswithinthe groupto ensuretheirproficiencyand competency in conductingstudies assigned to them. Each Scientist should be provided witha career development plan.

• Ensure professional development of self and staff by keeping up to date with advances inlab support,analytical,pharmaceuticaland regulatory developmentsas well as providing presentations for peers.

• Make recommendations tothe Managerforadditionalpersonnel and equipment resources that might be needed to meet our project commitments.

• Ensure the Manager isprovided withaweeklyrecap for departmental awareness.

• Participate in goal setting andconductperformance reviews for direct reports.

• Provide leadership to assigned staff by performing the following: developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals;supportingteams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

• Participate in continual improvement of the quality compliance systems within the Laboratory and champion continuous improvement (PPI) initiatives

• Support actions needed toinitiateand/or approveTrackwisechange control execution for any Lab Operation changes.

• Promoteandmaintaina safe working environment, report potential hazards, and ensure all direct reports follow Environmental Health and Safety procedures.

• Select, develop, and evaluate colleagues to ensure the efficient operation of the function. Work with and advise colleagues on administrative policies and procedures.

A/QPIC / A/RPICSummary(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 forfollowingthe Office of Controlled Substances (OCS) regulations and Company Standard Operating Procedures (SOPs) for the management of Narcotics and Controlled Drug Substances, and the Precursor Control Regulations and CompanySOPsfor the management of Class A Precursors.

• MinimumBachelor of Science (B.Sc.) inorganic chemistry, analyticalchemistryor a related sciencerequired.

• Minimum5yearspreviouspharmaceutical analyticallaboratoryoperation experience required.

• Minimum of2-3yearsprevioussupervisoryexperience required.

• Previousmethod and analytical instrumentation validation experience in the pharmaceutical industry.

• Exceptional Good Manufacturing Practices, Good Laboratory Practices, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and United States Food & Drug Administration (FDA) compliance knowledge.

• Ability to drive functional, technical, and operational excellence.

• Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.

• Abilityto help others develop skillsrequiredin a research and development environment andhelpsothers understand potential and areas for improvement.

• Ability to think strategically with the ability to direct the resolution of technical problems using innovative approaches.

• Applies data integrity and principles of Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).

• Excellent interpersonal and communication skills (both oral and written), leadership ability, and organizational skills.

• Strong ideas, decision making abilities, trouble shooting and thinking-out-of-the-box skills.

• Ability to build and drive cross-functional teams.

• Strong customer focus and commitment to results with strong problem-solving abilities.

• Capable ofsetting clear priorities,organizing work, and making quality decisions in a fast-pa