Supervisor, Formulation Manufacturing (PFS1, 12-hour days - B shift))

Job TitleWork Schedule: 12 hr shift/daysEnvironmental 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, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materialsJob DescriptionWhen you are part 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.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. Typical hours are 6a - 6p, on a 2-2-3 rotation.Role and Responsibilities:Help to ensure successful start-up of new Sterile facility by being a member of the site project team.Ensure new processes/procedures are developed and implemented in a timely manner to coincide with daring project timelines.Assist with building and training the production team that will staff the new Sterile Filling lines.Provide leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; encouraging 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.Supervise 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).Ensure that production schedule is met by distributing workload in accordance with changing priorities.Ensure 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.Evaluate/solve operation problems by reviewing the area of concern, developing potential solutions, technically evaluating, or testing the solutions, and preparing summary reports/recommendations for management.Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining systems.Prepare performance reviews for all employees and evaluate personnel performance according to performance management process. Provide feedback for continuous improvement. Hold staff accountable and apply disciplinary action as required. Assist in hiring staff as needed. Maintain a work environment with cultivate partnership and support the company's continuous improvement process.Provide training and/or opportunities for career development of staff.QualificationsEducation: High school diploma/GED minimally required. Associate's degree or Bachelor's degree in Science, Engineering, Administration, or other STEM related program is highly preferred.Experience: Minimum of 2 years of experience with a Bachelor's degree, 4 years of experience with an Associate's degree, or 6 years of experience with a high school diploma/GED, functioning in a pharmaceutical manufacturing or similar GMP environment.Experience in sterile drug formulation and manufacturing, and filling operations preferred.1+ years of previous leadership experience preferred.Experience in project management and leading start-up preferred.Experience with life virus vaccine techniques and procedures.Knowledge, Skills, AbilitiesKnowledge in GMPs 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.Ability to handle multiple ongoing activities and 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 driven.Demonstrated 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 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 example and set the example for others to follow.At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer!