Manager, Packaging/Labeling (3rd Shift)

Discover Impactful Work

The Manager, Packaging and Labeling is responsible for the daily oversight of clinical products processed through primary and secondary packaging operations. This role requires attention to details, the ability to interact with all levels of the organization, the desire to provide hands-on coaching and mentoring of staff, ability to communicate both verbally and written, and collaborate with cross-functional groups.

A Day in the Life

• Oversee workflow with an eye toward maximizing productivity, efficiency, and quality through ongoing review of data and metrics as well as use of PPI in a fast-paced environment.
• Maintain awareness of business results and financial results and ensure alignment with division goals.
• Apply Good Manufacturing Principles in all areas of responsibility.
• Demonstrate and promote the company through 4 I's - Intensity, Integrity, Innovation, and Involvement.
• Implement Standard Operating Procedures (SOPs) for manufacturing and packaging operations.
• Ensure training and adherence by all packaging associates for all cGMP and SOP guidelines as well as ensuring quality guidelines and timelines are met.
• Ensure adherence to health and safety policies and procedures.
• Responsible for product quality standards and SQIPP (Safety, Quality, Identity, Potency, and Purity) of the product.
• Analyze and monitor production to detect safety, quality, and productivity problems and trends. Create effective actions to resolve them.
• Resolve and own the labor and resources to meet production targets with consideration of client timelines, cost effectiveness, and workforce scheduling.
• Resolve and implement 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.
• Ensure effective cross-functional participation and collaboration with other relevant departments (e.g. Quality, Client Services, Facilities, etc.).
• Act as an effective Change Leader, supporting change and continuous improvement in the department.
• Perform other duties as assigned to meet the needs of business.

Keys to Success

Education

• Bachelor's degree is required.

Experience

• 3-5 years in a regulated environment (relevant cGXP industry such as Clinical Packaging, Commercial Pharmaceutical, Devices, etc.) required.
• 3-5 years of people management and/or leadership experience, serving as a role model for diversity and inclusion.

Knowledge, Skills, Abilities

• Exceptional leadership ability and excellent communication skills
• Thorough understanding of all packaging processes, SOPs, and cGMP requirements.
• Knowledge of Quality systems and standards
• Knowledge of Engineering principles and practices
• Sound eye for business, 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 manufacturing.
• Ability to think critically and problem solve
• Decision making skills
• Communication and influence skills
• Conflict Management
• Cultivation of collaboration and partnership
• 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.
• 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.

Environment

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 temperature-controlled, cold and frozen, environments.