Senior Manufacturing Manager

BIOSPECTRA SENIOR MANUFACTURING MANAGER

Bio Spectra is seeking a Senior Manufacturing Manager to lead the US manufacturing team and drive excellence in production operations. This leadership position is responsible for ensuring that the department meets production commitments, in compliance with the Company's quality, environmental and safety standards.

Major Roles & Responsibilities:

The ideal candidate will be able to perform the following responsibilities at a high level.

Manufacturing Team Leadership:

• Directs 24 hour/7-day manufacturing team to achieve production commitments, while maintaining efficiency and compliance with Company quality and EHS requirements.
• Communicates real-time status of on-time delivery attainment, quality compliance, efficiency and other critical production process parameters.

Production Scheduling & Inventory Management:

• Develops production schedules based on open orders, desired finished goods inventory levels and commercial on-time delivery commitments and projections.
• Orders supplies to support the manufacturing schedule.
• Delivers to production all materials or assurance of materials necessary to complete all production requirements.
• Coordinates the scheduling of preventative and other production related maintenance.

Quality Leadership:

• Works with manufacturing Managers and the Quality Assurance department to ensure that finished goods meet all current quality standards.
• Coordinates with the Supply Chain and Quality department to open batch records to support open orders.
• Works with the Quality department to investigate and resolve any discrepancies and/or quality issues related to manufacturing.
• Creates Temporary Operating Instructions (TOIs) as agreed upon and required for continuing production.
• Maintains and accepts full accountability and responsibility that all finished goods approved for shipment are in compliance with all quality and customer requirements.

Operating Procedure Compliance:

• Directs the training, assessment and enforcement of compliance with all policies and procedures related to the production, shipping and receiving departments.
• Creates, revises and maintains batch records.
• Authors, reviews and edits standard operating procedures related to production.
• Reviews production related documents to ensure on-going compliance with the Company's standards.

Environmental, Health & Safety:

• Ensures the training is completed and current of all manufacturing department employees on the Company's environmental, health and safety procedures.
• Ensures all waste generated by the department is handled in the Company's policies and procedures and federal, state and local regulations.

Manufacturing Training & Manufacturing Technician

Qualifications:

• Directs and oversees the training of production operators, consistent with all Company production, quality and EHS regulations and requirements.
• Oversees that the Manufacturing Technician Level Qualification system maintains high standards for level promotions and ensures that manufacturing management provides regular periodic reviews to manufacturing technicians on their performance.

Process Improvement:

• Develop and implement strategies for continuous improvements to the manufacturing process to enhance efficiency and quality.
• Submit recommendations to executive leadership for approval regarding process improvements and equipment upgrades to support the Company's objectives.

Process Development & Validation:

• Works with the Process Technology team to develop new processes and scale up for validation.
• Works with the Qualification and Validation team to review and approve equipment qualifications and process validations.

Resolving Process Challenges:
Identify and resolve production issues promptly, applying sound manufacturing process principles and problem-solving skills.

Qualifications:

The ideal candidate will have a degree in Engineering or other related field and a minimum of ten or more years' experience in manufacturing leadership with a manufacturer of products and/or or ingredients in life science, bio-pharmaceutical, food, fragrance or other materials related industries.

The ideal candidate will have the following qualities which will be…