Senior Associate, Manufacturing

AbbVie•North Chicago, IL

2d•$75,000 - $142,500

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 scheduled campaigns, schedule work tasks independently, and draft and manage broad-scope, complex documents through review and approval. Direct changeover activities with limited assistance and use judgment within broadly defined practices and policies to select methods and evaluation criteria. Track ongoing problems, gather and analyze information, 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, implement production initiatives, execute systems and procedures compliantly, identify improvement opportunities, and develop standard practices that promote consistency across groups. Coordinate daily operational activities across a unit or sub-unit and contribute to suite schedules and personnel allocation. Provide technical direction and training to less senior personnel, coordinate subgroup activities, advise the unit or sub-unit, participate in technical investigations, and provide on-the-floor technical expertise. Mentor colleagues and help foster a motivational, team-building environment. Work under general supervision, following established procedures; decisions are reviewed for technical soundness.

Requirements

Bachelor’s degree or equivalent.
At least 6 years’ 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.
Flexibility to handle multiple tasks and pressure in a professional and positive manner.
Ability to work effectively in a team environment and maintain energy and professionalism.
Ability to build effective working relationships with customers, coworkers, cross-functional groups, and management.
Problem-solving skills for complex problems requiring in-depth evaluation of various factors.
Ability to use discretion and work under general supervision, follow established procedures, and independently decide when minor adaptations or modifications are appropriate.
Ability to coordinate daily operational activities across a unit or sub-unit and contribute to suite schedules and personnel allocation.
Ability to provide technical direction and training to less senior personnel, coordinate subgroup activities, and mentor others.
Ability to interact with subordinates and functional peer groups at various management levels, gain cooperation, and present technical information.
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 compliance at plant level.
In-depth knowledge of pertinent regulatory filings.

Responsibilities

Support Production Leadership in continuous improvement, operational planning, day-to-day coordination, Operational Excellence initiatives, and technical writing.
Transfer methods into Production instructions to support successful scheduled campaigns.
Schedule work tasks independently to support project and campaign timelines.
Draft complex, broad-scope documents; circulate them for review, respond to comments and questions, and manage review and approval to meet project timelines.
Direct changeover activities with limited assistance.
Track ongoing problems, gather and analyze information, develop solutions, 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.
Understand production objectives, evaluate potential changes, and implement production initiatives.
Execute systems and procedures efficiently and compliantly, evaluate systems for improvement opportunities, and develop standard practices to ensure consistency across groups.
Coordinate daily operational activities across a unit or sub-unit and contribute to suite scheduling and personnel allocation.
Provide technical direction and training to less senior personnel; coordinate subgroup activities and work with other subgroups.
Advise the unit or sub-unit and become actively involved as required.
Participate in technical investigations and provide on-the-floor technical expertise.
Mentor colleagues and contribute to a motivational, team-building atmosphere.
Discuss progress, problems, and proposed solutions with colleagues and senior personnel; present technical information concerning projects and schedules.
Recommend improvements to plant-level compliance and apply current Good Manufacturing Practices to equipment and process steps in the area of responsibility.