We are seeking 2x Drug Product Manufacturing Supervisor to lead aseptic manufacturing operations at the company’s 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.
