Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

Summary:

Manages team responsible for environmental/equipment monitoring, purified water, finished product, and stability sample testing in the Microbiology laboratory. Ensures adequate training is conducted and acceptable testing is performed for release of all test samples. Investigates and documents out of specification results.

Essential Functions: 

Supervises, coaches and develops the microbiology staff in the performance of their duties.Reviews/approvals of specification, protocols and reports.Schedules microbiological testing.Investigates Out of Specification (OOS) results, initiates OOS, Deviation Reports (DRs)/Quality Investigation Reports (QIRs) and change control documents.Manages Standard Operating Procedure (SOP) changes for departmental improvements/auditInterprets and troubleshoots equipment/test problems effectively and meeting deadlinesLead new capability implementation including but not limited to micro limits testing, raw material rapid testing, improvement of existing and development of new laboratoryDesign, plan and lead certain continuous improvement (PPI) projects/initiatives focusing on upgrading scientific practices / knowledge, driving best practices / standard work and/or quality initiatives. Engage in client projects as needed to guide collaboration problem resolution both externally and internally.  Drive staff development, recruitment and performance management Manage operational performance using key performance indicators Provide technical support to Business Management, Tech Transfer, Project Management, Technical Operations and actively participates in customer projects. Ensure good working relationships with the site management and all other departments  Manage operational performance using key performance indicators Promote a safe working environment, report potential hazards, and ensure all direct reports follow the Environmental Health and Safety procedures.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:

Bachelor of Science (B.Sc.) in Microbiology

Experience:

Minimum 7 years microbiology experience

Minimum of 5 years previous supervisor or manager experience.

Equivalency:

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

Knowledge, Skills and Abilities:

Solid knowledge of Good Laboratory Practices (GLP).  Excellent knowledge of Good Manufacturing Practices (GMP).  Excellent verbal and written communication skills.  Well organized and detail oriented with the ability to meet deadlines and prioritize.  Strong interpersonal and leadership skills. Capable of setting clear priorities, organizing work, and making quality decisions in a fast-paced setting.  Proficiency using MS Office applications.  Proficiency with English language.

Standards and Expectations:   

Follow all Environmental Health & Safety Policies and Procedures. Work harmoniously 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 SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators (KPI's) and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models 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 of deliverables in a proactive manner.  Consistently strives to improve skills and knowledge in related field.    

Physical Requirements:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area.  There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

Disclaimer: 

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.