Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Laboratory Setting

Job Description

As part of the Thermo Fisher Scientific team, you’ll 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 world’s 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:

• 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.

• Ensure cGMP and Environmental Health & Safety compliance as well as good laboratory housekeeping and documentation practices of direct reports.

• 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.

• 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).

• 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.

• 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.

• Supports development of test methods and their respective validation along with review of the protocols/reports.

• Support execution of method transfers/verifications for Analytical Development team.

• Support the method training of Analytical Operations team when products and test methods move from development to commercial testing.

• Support development and execution of PDS Stability protocols and their respective reports along with SAR (LIMS Stability Analytical reports) approval.

• Support the execution of PDS laboratory-related quality events (OOS/UR’s, DR’s, CAPA’s, EC’s) to drive on time and scientifically sound closures.as well as approval of the Lab Incident Records.

• Ensure External Lab test results are received in a timely manner.

• Engage with clients and Business/Project Managers to provide updates to timelines and remove roadblocks to meet timelines.

• 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.

• Ensure professional development of self and staff by keeping up to date with advances in pharmaceutical and regulatory developments.

• Support, develop and implement departmental continuous improvement PPI initiatives.

• 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.

• Maintain excellent communications with DO Lab Manager and Technical Leads to ensure awareness of any deviations of required performance standards.

• Ensure the Manager is provided with a weekly recap for departmental awareness

• Participate in goal setting and conduct performance reviews for direct reports.

• Support actions needed to initiate and/or approve Trackwise change control execution for any Lab Operation changes.

• Drive staff development, recruitment and performance management

• Promote and maintain a 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.

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 (SOP’s) for the management of Narcotics and Controlled Drug Substances, and the Precursor Control Regulations and Company SOP’s for the management of Class A Precursors.

Essential Functions:

§ Issue and return Narcotic & Controlled Drug Substances and Class “A” Precursor materials from their secure zones (approved licensed storage locations) to facilitate the timely execution of processing, packaging and shipping activity.

§ Secure Narcotics & Controlled Drug Substances rejects, and Class “A” Precursor rejects and maintain monthly inventory.

§ Manage and witness Narcotic & Controlled Drug Substances destruction.

§ Manage the Class “A” Precursor destruction process.

§ Complete log entries as per procedural requirements and maintain records to facilitate monthly and annual reports.

§ Process Narcotics & Controlled Drug Substances and Class “A” Precursor samples

§ Maintains excise records for alcohol usage and prepares monthly returns.

§ Maintains Narcotic data-base & reconciles it with log sheets in all 5 locations of Narcotics and controlled substances.

§ Co-ordinates with OCS, RCA & Health Canada on all outstanding observations to remain in compliance.

§ Performs Annual Inventory of Class “A” Precursors by physical count and submits report to Health Canada

§ 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

§ Facilitates in import / export permits for Narcotics & Controlled Drug Substances and Class “A” Precursors.

§ Maintains Narcotics & Controlled Drug Substances locations within illicit value limits assigned by Health Canada.

§ 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.

§ Completes annual criminal background check as part of QARA-P0007, Narcotics Policy and POL-000105180 – PSG Controlled Substance Policy

§ Participates in random employee searches as part of Anti-Theft/Employee Assigned Company Property Inspection Policy (Mississauga and Whitby, PSG) CAN-HR-Policy-370

§ Participates in random drug testing as part of QARA-P0007, Narcotics Policy and POL-000105180 – PSG Controlled Substance Policy - not applicable to Canadian employees.

§ Maintain Narcotics & Controlled Substances and Class A Precursor procedures to ensure alignment to corporate policies and regulations

§ Manage Narcotics & Controlled Substances and Class A Precursor Regulatory, Corporate, and Internal Audits

§ Collaborate with auditors and represent the site as required during inspections to ensure information is provided in a timely, accurate and complete manner.

§ Maintain awareness of regulatory intelligence in support of gap identification and mitigation to ensure compliance.

§ Provide ongoing coaching and mentoring to site A/QPICs and A/RPICs to ensure compliance to requirements across the site.

§ 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.

§ Responsible to ensure the designated A/RPIC is trained to assume RPIC responsibilities for Class “A” 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 years’ previous pharmaceutical analytical laboratory setting experience

Minimum of 3 years’ 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 $84,900.00–$112,000.00.