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 (cGMP), current Good Laboratory Practices (cGLP), Corporate Quality Standards 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 Stability testing in support of client projects and timelines.
A Day in The Life:
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.
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 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.
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.
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
Experience:
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.
Ability to build and drive cross-functional teams.
Strong customer focus and commitment to results with strong problem-solving abilities.
Capable of setting clear priorities, organizing 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.
