Work Schedule
12 hr shift/nights

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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

COMPANY INFORMATION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or increasing efficiencies in their laboratories, we are here to support them. Our global organization of more than 100,000+ 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.

• Provide 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.
• Ensure that established standards, including production, quantity and quality are met. Take direct action to correct deviations and report variances and exceptions to the assigned position supervisor and follow up on corrective action.
• Ensure that all production operations are validated and fully follow all Current Good Manufacturing Practices (cGMPs). Responsible for area compliance for the FDA, QAT, and OSHA inspections.
• Use available resources effectively; plans, monitors, meets, and (if required) revise daily production schedules as measured by comparison of actual production with scheduled production to produce a quality product in an efficient manner.
• Administer department safety programs so that operative personnel understand and follows safety rules and procedures. Follow all job-related safety and other training requirements
• Evaluate performance and skills of personnel and communicate same so that performance is continually improved and skills are progressively developed. Take corrective action when required. Perform annual employee evaluations.
• Assist technical staff and customers in technical issues to ensure new transferred processes are robust and validated. Approve process validation protocols.
• Establish and approve the technical requirement for production documentation including equipment and systems specifications, manufacturing formulas, POMS procedures, filling and packaging work orders, Standard Operating Procedures (SOPs), Environmental Procedures, PMs, etc.
• Implement cost reduction programs to stay competitive in the present economy.
• Track employees attendance, approval of time cards, trainings, etc.
• Perform other duties as assigned.

• Bachelor's degree required, in Physical, Biological, Chemical or Production related science is preferred.
• 5+ years of manufacturing experience with 2 years of prior leadership experience required. Experience in a steriles pharmaceutical manufacturing environment preferred.
• Equivalent combinations of education, training, and relevant work experience may be considered.
• Technical and operational knowledge of aseptic processing operations, ability to handle multiple ongoing activities, and ability to prioritize tasks.
• Outstanding attention to detail and organizational skills.
• Self-starter, mature, independent and reliable.
• Ability to work in a fast paced environment under pressure, able to multi-task and drive for results.
• Demonstrates ability to maintain a high degree of confidentiality.
• Effective time management and prioritization skills.
• Requires discretion and independent judgment.
• Very strong interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
• Highly effective verbal and written communication skills.
• 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.