Senior Associate, Manufacturing - North Chicago, IL

Military Spouse Corporate Career Network•North Chicago, IL

11d•$75,000 - $142,500•Onsite

About The Position

Support Production Leadership in continuous improvement, operational planning, day-to-day coordination, Operational Excellence initiatives, and technical writing to drive safe, compliant, and efficient manufacturing operations. Transfer methods into Production instructions to support successful execution of scheduled campaigns, and schedule work tasks independently to support project and campaign timelines. Draft broad-scope, complex documents; circulate them for review; respond independently to comments and questions; and manage review and approval to meet project timelines. Direct changeover activities with limited assistance. Track ongoing problems, gather information for analysis, develop solutions to broad-level problems, present potential solutions to management and senior personnel, and create implementation plans with limited assistance. Evaluate data for trends that may affect other systems, projects, or areas. Apply technical knowledge and experience to understand production objectives, evaluate potential changes, and implement production initiatives. Execute systems and procedures efficiently and compliantly, evaluate opportunities for improvement, and develop and use standard practices to ensure consistency across groups. Coordinate daily operational activities across a unit or sub-unit, contributing to suite schedules and personnel allocation. Provide technical direction and training to less senior personnel, coordinate subgroup activities, participate in technical investigations, and provide on-floor expertise. Act as an advisor and mentor, foster a motivating, team-building atmosphere, and communicate progress, problems, and proposed solutions with colleagues and senior personnel. Apply a detailed understanding of current Good Manufacturing Practices and pertinent regulatory filings, and recommend improvements to plant-level compliance.

Requirements

Bachelor’s degree or equivalent.
At least 6 years of experience in all aspects of manufacturing and production processes.
Knowledge of media and buffer preparation, cell culture, and purification of biological drugs.
Computer expertise and scheduling proficiency.
In-depth knowledge of safety, quality systems, and current Good Manufacturing Practice.
Expertise with the tech transfer process and familiarity with equipment, facilities validation, and regulatory filings.
Ability to handle multiple tasks and pressure professionally and positively.
Ability to work effectively in a team and build working relationships with customers, coworkers, cross-functional groups, and management.
Problem-solving skills for complex issues requiring in-depth evaluation of multiple factors.
Ability to use discretion and work under general supervision while following established procedures.
Ability to make minor adaptations or modifications independently.
Detailed understanding of current Good Manufacturing Practices as applied to equipment and process steps in the area of responsibility.
Ability to make recommendations for improved plant-level compliance and in-depth knowledge of pertinent regulatory filings.

Responsibilities

Support Production Leadership with continuous improvement, operational planning, daily coordination, Operational Excellence initiatives, and technical writing.
Transfer methods into Production instructions for scheduled campaigns.
Schedule work tasks independently to support project and campaign timelines.
Draft complex, broad-scope documents; coordinate reviews and approvals; respond to reviewer comments; and meet project timelines.
Direct changeover activities with limited assistance.
Track problems, gather and analyze information, develop solutions, and create implementation plans with limited assistance.
Evaluate data for trends and implement production initiatives and potential process changes.
Execute and assess systems and procedures for efficiency, compliance, and improvement opportunities.
Develop and use standard practices to support consistency across groups.
Coordinate daily operations across a unit or sub-unit, contributing to suite schedules and personnel allocation.
Provide technical direction and training to less senior personnel; coordinate subgroup activities; and mentor colleagues.
Participate in technical investigations and provide on-the-floor technical expertise.
Communicate progress, problems, and proposed solutions to colleagues, management, and senior personnel.
Recommend improvements to plant-level compliance.