Essential Functions:

• Supervises a Team of 4-6 Scientists who are responsible for the execution of laboratory instrumentation preventative maintenance, qualification and validation activities.

• Ensures instruments are calibrated and preventative maintenance is performed as scheduled.

• Assigns tasks within the group to ensure completion.

• Performs routine calibration and validation of all equipment according to schedule.

• Assigns tasks within the group to ensure completion.

• Updates calibration, performance verification and preventative maintenance SOPs to keep current with Good Manufacturing Practices requirements.

• Coordinates external outside calibration and preventative maintenance services, if required.

• Performs Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) on all new equipment.

• Maintains the calibration and preventative maintenance schedules for each new and existing piece of analytical equipment.

• Sets up systems to continually improve the metrology, lab assistants and QC laboratories to ensure increasing effectiveness of service.

• Performs and completes performance appraisals throughout the year.

• Selects, develops and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures.

• Performs alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS

Education:

Minimum Bachelor of Science (B.Sc.) in Chemistry or a science related to pharmaceutical analysis

Experience:

Proven experience in quality control/analytical development within the pharmaceutical industry

Previous Supervision and/or leadership and training experience

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Previous method and analytical instrumentation validation experience in the pharmaceutical industry. Possesses a highly developed quality, regulatory and production attitude including an appreciation for client service and contract manufacturing. Excellent knowledge of Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Well organized and detail oriented. Strong interpersonal and communication skills (both oral and written). Demonstrated leadership skills. Ability to read, analyze, and interpret technical procedures and governmental regulations. 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. Carry out 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.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage 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 a proactive manner. Consistently strives to improve skills and knowledge in related field.

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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.