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Thermo Fisher Scientific Sr. Manager, Technical Operations in Allentown, Pennsylvania

COMPANY INFORMATIONThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues 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 and Patheon. For more information, please visit www.thermofisher.com . GROUP/DIVISION SUMMARYThe Clinical Trials Division (CTD) within the Pharma Services Group partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally embrace as 'There is a Patient Waiting.' Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters

How will you get here?

  • Bachelor's degree and a minimum of 8-15 years in a regulated environment (relevant cGXP industry such as Clinical Packaging, Commercial Pharmaceutical, Devices, etc.). Experience in a Manufacturing or Production environment required. Bachelor's degree in Engineering, or similar, preferred.

Responsibilities

  • Applies Good Manufacturing Principles in all areas of responsibility.

  • Demonstrates and promotes the company vision through Thermo Fisher's 4 I's - Intensity, Integrity, Innovation, and Involvement.

  • Monitor daily and long-term business requirements and ensure equipment is in a state of readiness to meet required output.

  • Responsible for overseeing all manufacturing and packaging equipment and related activities. Prioritize work assignments in response to required manufacturing and packaging activities.

  • Responsible for the creation and implementation of Standard Operating Procedures (SOPs) for Equipment on manufacturing and packaging operations.

  • Responsible for ensuring training and adherence by all equipment technical personnel for all cGMP and SOP guidelines.

  • Role model for advocacy and adherence to health and safety policies and procedures.

  • Responsible for product quality standards and SQIPP (Safety, Quality, Identity, Potency, and Purity) of the product and ensuring quality guidelines and timelines are met.

  • Analyzes and monitors production to detect safety, quality, and productivity problems and trends. Creates effective actions to resolve them, with appropriate sense of urgency.

  • Determines and manages the labor and resources regarding equipment support to meet production targets with consideration of client timelines, cost effectiveness, and workforce scheduling.

  • Continuously assess, and advance, technical expertise of team and enable development activities to advance skill sets.

  • Manages decision-making about equipment utilization and overall maintenance. Prioritize tasks in accordance with business needs.

  • Monitors and reviews performance of personnel and ensure necessary actions are taken to ensure development and improvement.

  • Create strategic plan and budget planning for equipment maintenance, expenditure, and replacement. Ensure maintenance and equipment transitions are well planned and create minimal business interruption.

  • Sustain a service-oriented culture with appropriate levels of urgency, working in collaboration and partnership with peer groups.

  • Determines and implements improvements to the production process by participating and actively encouraging a culture of Continuous Improvement through Thermo Fisher's Practical Process Improvement (PPI) business model. Serves as a role model for challenging the status quo.

  • Ensure effective cross-functional participation and collaboration with other relevant departments (e.g. Quality, Client Services, Facilities, etc.).

  • Acts as an effective Change Leader, supporting change management and continuous improvement in the department.

  • Performs other duties as assigned to meet the needs of business

Knowledge, Skills, Abilities

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.

  • A minimum of 3-5 years of progressive people management and leadership experience, serving as a role model for diversity and inclusion

  • Exceptional leadership ability and excellent communication skills

Thorough understanding of all packaging processes, SOPs, and cGMP requirements

  • Strong technical and analytic acumen

  • Knowledge of Quality systems and standards

  • Knowledge of Engineering principles and practices

  • Sound business acumen, with knowledge of financial principles and practices

  • Knowledge and experience in operations management

  • Knowledge of human resources practices

  • Knowledge of project management practices

  • Knowledge of lean principles and practices

  • Ability to think critically and problem solve

  • Decision making skills

  • Communication and influence skills

  • Conflict Management

  • Cultivation of collaboration and teamwork

  • Adaptability, and ability to multi-task in an environment where priorities may change on a daily basis

  • Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.

Physical Requirements

  • Must be able to stand continuously (95%-100%)

  • Must be able to walk frequently (50% - 79%)

  • Must be able to sit (up to 49%)

  • Must be able to lift and or carry the max of 50 pounds frequently (50%-79%)

  • Must be able to bend frequently (50%-79%)

  • Must be able to squat (up to 49%)

  • Must be able to reach above shoulder level essentially (80%-94%)

  • Must be able to use both right and left hand for repetitive action, simple grasping, pushing and pulling and fine manipulation essentially (80%-94%)

  • Must be able to use both the right and left foot for repetitive action occasionally (up to 49%)

  • Vision requirements for this position: close vision (clear vision at 20 inches or less), distance vision (clear vision at 20 feet or more), color vision, peripheral vision (ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point), depth perception (three dimensional vision) and the ability to adjust focus.

  • Personal Protective Equipment Certification (PPE) including but not limited to filtering face masks, PAPR, N-95 masks, half face masks and safety glasses is required to perform this position

  • Must be able to work in both temperature-controlled, cold and frozen, environments

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

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.

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