Lab Operations Manager / Consultant - Large Molecule

Our client is looking for a consultant with deep experience in Lab Operations Management. The role is located near Morton Grove and will require working at the client site. (No remote candidates please). No relocation is required, but the role will require working at the client site with expenses covered.

Option 1 - Sr. consultant - 4 to 6 month contract - Assessing current state vs future needs and putting place processes to create opex and scalability. Shorter-term contract with a more senior person who would come in and get best practices set up.

Option 2 - Staff aug - 12-month contract - more tactical, high speed and complexity. This will report into a Sr. Manager of Quality Control. Longer term contract doing the work / running the lab operations.

Lab Operations Manager / Consultant:

• Primary focus will be sample logistics and inventory management for all internal and external testing (GMP and otherwise)
• Laboratory operations efficiency - maintaining instrument uptime; PM calibration on all instruments scheduled and performed. (in such a way that its not disruptive to operations)
• Reagent standard and other consumables inventory management
• Implementation of tools to support operational efficiency and trend analysis and reporting

They anticipate that very little of this will be SOP governed, it will be much more following basic SOPs for documentation and then figuring out how to create efficiencies and scalabilities into the lab. It's fast-paced and there is a lot of activities, e.g. 3 dozen POs, tracking expiry dates on agents, monitoring instruments e.g. when the HPLC needs to be calibrated next, pulling 130+ samples from runs each week into different storage locations etc.

The perfect candidate would have some supply chain background and/or some biotech /laboratory background. Operational excellence and statistical analysis capabilities. Could be a white- or blue-collar background. If someone has managed a contract lab or handled logistics and purchasing for a clinical or medical lab, that would be transferable.

Primarily for Quality Control (QC) labs but may also support development and research labs.

Expanded Description:

Primary Focus:

• Sample Management: Oversee the efficient handling, tracking, and storage of samples for both internal and external testing, ensuring compliance with GMP and other relevant regulations.
• Inventory Management: Manage the inventory of reagents, standards, consumables, and other laboratory supplies to optimize stock levels and minimize disruptions to operations.
• Instrument Maintenance: Implement a robust maintenance schedule for all laboratory instruments, including preventive maintenance and calibration. Coordinate with vendors for timely repairs and calibrations, minimizing downtime and ensuring optimal instrument performance.

Laboratory Operations Efficiency:

• Process Optimization: Continuously evaluate and optimize laboratory workflows to improve efficiency and reduce turnaround time.
• Data Management: Implement and maintain a robust data management system to track sample information, instrument performance, and experimental results.
• Quality Assurance: Ensure adherence to quality control standards and regulatory requirements through regular audits and inspections.

Additional Considerations:

• Regulatory Compliance: Stay updated on relevant industry regulations (e.g., FDA, EMA) and ensure compliance in all laboratory operations.
• Safety: Prioritize laboratory safety by enforcing safety protocols and conducting regular safety training.
• Collaboration: Work closely with scientists, engineers, and other stakeholders to understand their needs and provide effective support.

***Please no third party vendors.