Senior Associate, Manufacturing - North Chicago, IL
About The Position
The Senior Associate, Manufacturing supports Production Leadership with continuous improvement, operational planning, day-to-day coordination, Operational Excellence initiatives, and technical writing to help drive safe, compliant, and efficient manufacturing operations. The role transfers methods into Production instructions to support successful scheduled campaigns and independently schedules work tasks to meet project and campaign timelines. The position drafts complex, broad-scope documents, coordinates their review and approval, and responds to reviewer comments and questions. It directs changeover activities with limited assistance, tracks operational problems, analyzes data and trends, and develops and presents potential solutions and implementation plans. The role applies technical knowledge to production objectives and potential changes, executes and evaluates systems and procedures, and develops standard practices to promote compliance and consistency between groups. The role also coordinates daily operational activities across a unit or sub-unit, contributes to suite schedules and personnel allocation, provides technical direction and training to less senior personnel, and participates in technical investigations. It acts as an advisor and mentor, collaborates across groups, and provides on-floor technical expertise.
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 (cGMP).
- Expertise with the tech transfer process and familiarity with equipment, facilities validation, and regulatory filings.
- Flexibility to handle multiple tasks and pressure professionally and positively.
- Ability to work effectively in a team and build effective 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 cGMP as applied to equipment and process steps in the area of responsibility.
- In-depth knowledge of pertinent regulatory filings.
Responsibilities
- Support Production Leadership with 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; coordinate document review and approval; and respond to reviewer comments and questions.
- Direct changeover activities with limited assistance.
- Track ongoing problems, gather information, analyze issues, develop potential solutions, present them to management and senior personnel, and create implementation plans with limited assistance.
- Evaluate data for trends that could affect other systems, projects, or areas.
- Apply technical skills and experience to understand production objectives, evaluate potential changes, and implement production initiatives.
- Execute systems and procedures efficiently and compliantly, evaluate them for improvement opportunities, and develop standard practices for inter-group consistency.
- 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, and work with other subgroups.
- Participate in technical investigations and provide on-floor technical expertise.
- Mentor personnel and foster a motivational, team-building atmosphere.
- Discuss progress, problems, and proposed solutions with colleagues and senior personnel, including presenting technical information about projects and schedules.
- Recommend plant-level improvements to compliance.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
