Supervisor Analytical Operations (Afternoon Shift)

JOB DESCRIPTION

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Title: Supervisor Analytical Operations (Afternoon Shift)

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.

Division/Site Specific Information

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

Discover Impactful Work:

Supervise the activities of an Analytical Operations (AO) Group, within Laboratory Operations, ensuring that all Standard Operating Procedures (SOP), current Good Manufacturing Practices (c GMP), current Good Laboratory Practices ( c GLP ) , C orporate Q uality S tandards and client objectives/timelines are achieved.

Supervise a Team of 10-14 Scientists who are responsible for the execution of product evaluation/ CofA release and commercial S tability testing in support of client projects and timelines .

A Day in The Life:  

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

• Provide technical leadership for analytical challenges.

• Conduct weekly direct report team huddles in order to facilitate problem solving and communication.  Maintain accountability of the team for standard work, compliance, scientific integrity , documentation and project execution.

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

• Ensure that all AO laboratory documentation within the group is completed 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 completed in accordance with approved test methods and SOP’s .  

• Ensure all LIMS Certificate of Analysis ( CofA ); Analytical Release Form (ARF) and Control Procedure (CP) are current and accurate . 

• Ensure Follow-Up Stability Testing (FUST) and any other commercial Stability stud y testing are completed on time to avoid deviations .

• Ensure customer complaints are supported as needed.

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

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

• Design and monitor progress against the schedules for each Scientist in the g roup . E nsure that studies are completed in accordance with project timelines, On Time Delivery (OTD) dates and client expectations.

• Supervise the training of all Scientists within the group to ensure their proficiency and competency i n conducting studies assigned to them . Each Scientist should be provided with a career development plan.

• Ensure professional development of self and staff by keeping up to date with advances in lab support, analytical, pharmaceutical and regulatory developments as well as providing presentations for peers .

• Make recommendations to the Manager for additional personnel and equipment resources that might be needed to meet our project commitments.

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

• Participate in goal setting and conduct performance 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; supporting teams 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 to initiate and/or approve Trackwise change control execution for any Lab Operation changes.

• 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.

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.

Keys to Success:

Education

• Minimum Bachelor of Science (B.Sc.) in organic chemistry, analytical chemistry or a related science required.

Experience: 

• Minimum 5 years’ previous pharmaceutical analytical laboratory operation experience required .

• Minimum of 2-3 years’ p revious s upervi sory experience required.

Knowledge, Skills, and Abilities:

• Previous method 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 . 

• Ability to help others develop skills required in a research and development environment and helps others 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 . 

• A bility to build and drive cross-functional teams .  

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

• Capable of setting clear priorities, o rganizing work, and making quality decisions in a fast-paced business setting.

• Experience with Microsoft Office Applications .

• Proficiency in the English Language.

Standards and Expectations:  

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives . Perform all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Always be client and patient conscious. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engaging in problem solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in an initiative-taking manner.  Consistently strive to improve skills and knowledge in related fields .   

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

Compensation

The estimated annualized pay range for this position in Ontario is $76,400.00–$114,575.00.