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/audit Interprets and troubleshoots equipment/test problems effectively and meeting deadlines Lead new capability implementation including but not limited to micro limits testing, raw material rapid testing, improvement of existing and development of new laboratory Design, 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
