Thermo Fisher Scientific

Work Schedule

Flex 12 hr shift/days

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

When you are part of the team at Thermo Fisher Scientific, you’ll 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 you’ll be supported in achieving your career goals.

Location/Division Specific Information

How will you make an impact:

Lead the Steriles North manufacturing team 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. This role will on a 2-2-3 rotation day shift from 6am - 6pm.

Role and Responsibilities:

• Help to ensure successful start-up of new Sterile facility by being a member of the site project team.
• Ensures new processes/procedures are developed and implemented in a timely manner to coincide with daring project timelines.
• Assists with building and training the production team that will staff the new Sterile Filling lines.
• 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 interpersonal goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and crafting 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 collaborating with employees to ensure that every product unit is of high quality and exceeds all current Good Manufacturing Practices (cGMPs).
• Ensures that 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 to 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 performance management process. Provides feedback for continuous improvement. Holds staff accountable and employs coaching process as required. Assists in hiring staff as needed. Maintains a work environment with cultivate partnership and supports the company’s continuous improvement process.
• Provides training and/or opportunities for career development of staff.

Education:

Bachelor’s degree in Science, Engineering, Administration, or other STEM related program is preferred.

Experience:

• Minimum four (4) years of technical and/or manufacturing experience.
• One (1) to five (5) years of supervisory experience preferred.
• Experience in project management and leading start-up, preferable.
• Experience with life virus vaccine techniques and procedures

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

Knowledge, Skills, Abilities:

Knowledge in GMP’s and FDA regulations.

Technical writing experience, preferred.

Technical and operational knowledge of start-up of aseptic environment for live virus vaccines.

Strong decision-making skills.

The ability to handle multiple ongoing activities and ability to prioritize tasks.

Outstanding attention to detail and organizational skills.

Capable of flourishing in a fast-paced environment, able to handle pressure and effectively manage multiple tasks.

Demonstrates ability to maintain a high degree of confidentiality.

Excellent social 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 SOP’s, 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 example set the example for others to follow

At Thermo Fisher Scientific, we offer competitive benefits packages.