Work Schedule Other Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description How will you make an impact: Accountable for the processing of pharmaceuticals to meet quality standards (e.g. full cGMP, health, safety and environmental compliance), cost targets, delivery dates, while ensuring proper staffing levels, including hiring and training of staff and the continuous development of existing associates. Work with internal and external auditors, clients, equipment vendors, component suppliers and other internal and external contracts as needed. Reviews / approves master production documents, validation reports and SOPs. Shift Schedule: Monday – Friday; Days and Afternoons rotation What will you do: Ensure department has the adequate resources to meet the master production schedule and planning is such that start times are honored (e.g. hiring of staff, shift structure, etc). Weekly Targets & Plan Setting. Assist in daily scheduling via communication priorities, informing key staff of shipping dates, etc. Monitor daily production outputs (e.g. output quantity, etc.) and efficiencies. Monitor costs to ensure optimum operating while maintaining production costs. Complete projects assigned by Management within established timelines. Prepare quotations for existing products and future prospective clients. Develop and implement a succession plan and career path for all key individuals. Outline clearly key staff roles and expectations, as required. Develop training curriculum and provides annual performance reviews to Supervisors and Group Leaders. Ensure the necessary training is provided to the individuals such that they are able to excel in their position and to monitor the performance of those who require help or direction. Support cross training of individuals thus achieving a flexible work force, as required. Hire staff and administer performance improvement plans, up to and including termination when appropriate. Ensure excellent product quality as demonstrated in downward trend of Quality Investigation Reports/Quality Deviation Reports (QIR/QDRs) through more awareness to issues and expectations and excellent root cause identification and elimination. Offer options and suggestions for process, capacity, client services and staff morale improvements. Ensure responses to client, Good Manufacturing Practices, safety and QIR follow-up actions are completed in a timely manner, as required. Assist in investigating and resolving technical issues. Monitor processes to ensure efficient operation (e.g. yields). Instill a culture of professionalism and respect for co-workers, clients and the products with which we work. Promote a safe working environment, report potential hazards and ensure all direct reports follow 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. How will you get here: Education: Bachelors degree in Engineering, Sciences or related field. Experience: Minimum 6 years manufacturing operations experience in a pharmaceutical industry or other GMP environment. Minimum 3 years previous supervisory experience. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Competencies: Proven ability to coach and develop staff as well as the technical ability to coordinate departmental business activities. Full knowledge of Good Manufacturing Practices requirements and pharmaceutical processing regulations. Strong leadership, team building and organizational skills. Demonstrated computer proficiency with Microsoft Office programs including the ability to develop spreadsheets, presentations and reports. Proficiency with 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 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 centric 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. 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 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. Benefits We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation. 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.
