Job Description

When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have a real-world impact, and youll be supported in achieving your career goals.

Location/Division Specific Information

Pharmaceutical Services Group

How will you make an impact?

Lead the team who supports the startup and commercialization of Steriles Operations Projects; providing technical, mechanical and leadership to the operations activities in the assigned. Supervises operations employees of high-quality pharmaceutical products according to schedules, cost, and quality standards, while maintaining employee engagement, safety performance, and ensuring adherence to all regulatory control and documentation procedures.

What will you do?

* Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
* Supervises employees in day to day operations by spending at least 50% of available time interfacing with employees to ensure that every product unit is of high quality and exceeds all the Companys current Good Manufacturing Practices (cGMPs).
* Ensures the production schedule is met by distributing workload in accordance with changing priorities.
* Ensures production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOPs) are accurate, training is current, critical documentation templates are accurate, equipment is in good repair and current calibration, and high standards of housekeeping are maintained in all areas of responsibility.
* Evaluates/solves operation problems by reviewing the area of concern, developing potential solutions, technically evaluating or testing the solutions, and preparing summary reports/recommendations for management.
* Assures compliance with all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.
* Prepares performance reviews for all employees and evaluates personnel performance according to the performance management process. Provides feedback for continuous improvement. Holds staff accountable and applies discipline process as required. Assists in hiring staff as needed. Maintains a work environment with fosters teamwork and supports the companys continuous improvement process.
* Provides training and/or opportunities for the career development of staff.
* This position will start as an 8 hour (M-F) days transitioning to 12-hours rotating shifts (nights). Rotation is 2-2-3.

How will you get here?

Education

Associate or Bachelors degree in Science, Engineering or other STEM-related programs, preferable

Experience

* Four (4) years of technical and/or manufacturing experience.
* One (1) to five (5) years of supervisory experience preferred.
* Experience in vaccine manufacturing / fill preferred.
* Experience in quality, technical and mechanical skills
* Experience in project management and leading start-up, preferable

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

Knowledge, Skills, Abilities

* Knowledge in GMPs and FDA regulations
* Strong decision-making skills.
* Technical and operational knowledge of aseptic processing operations
* The ability to handle multiple ongoing activities, and the ability to prioritize tasks.
* Outstanding attention to detail and organizational skills.
* Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented.
* Demonstrates the ability to maintain a high degree of confidentiality.
* Excellent interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
* Highly effective verbal and technical written communication skills. Able to create SOPs, work instructions and manufacturing process.
* Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff. Lead by the example set the example for others to follow

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.