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Manufacturing Operations Manager
4 weeks ago
We are seeking a highly skilled Manufacturing Operations Manager to lead aseptic manufacturing operations at our Chicago facility.
This role is critical in ensuring the production of high-quality products that meet all regulatory requirements, driving the company's ambitious growth plans.
Key Responsibilities:
Lead daily manufacturing operations, ensuring efficient use of equipment and materials to meet a rapidly expanding production schedule under cGMP guidelines.
Mentor and coach team members, conducting performance reviews, and ensuring the development of staff to meet the demands of increased output.
Ensure compliance with safety and regulatory standards, adhering to company policies, environmental, health, and safety (EHS) regulations, and cGMP requirements.
Oversee training of personnel on processes, equipment, and Standard Operating Procedures (SOPs), scaling operations effectively as production ramps up.
Develop and maintain packaging schedules, participate in budget planning, and ensure alignment with departmental goals as output increases.
Participate in qualification, validation activities, and CAPA investigations to ensure process improvements are implemented efficiently and support scale-up efforts.
Collaborate across departments to ensure smooth workflow, sharing best practices and applying lean manufacturing principles to maximize output.
Monitor production metrics using databases and spreadsheets, ensuring accurate reporting and compliance with documentation standards.
Investigate and resolve production issues, implementing process improvements to support the company's ambitious growth plans.
Requirements:
Bachelor's degree in engineering, life sciences, or a related field. A Master's degree is an asset.
Prior experience in aseptic manufacturing operations is a must.
Hands-on experience with manual visual inspection of PFS and vials.
Experience in finished product packaging and serialization is highly preferred.
Strong leadership and communication skills, with the ability to guide teams through rapid operational growth.
Problem-solving expertise, with a focus on maintaining high standards of quality and efficiency.
Proficiency in technical writing, including the ability to author SOPs and manage deviations.
In-depth knowledge of cGMP and FDA regulatory requirements.
