Manufacturing Associate II (Sunday to Wednesday, 4:00pm - 2:30am)

Responsibilities

• Transfers methods into Production instructions to allow for successful performance of scheduled campaigns.
• Schedules work tasks, with limited assistance, to support project/campaign timelines. Drafts diverse scope and complexity documents. Circulates documents to reviewers with limited assistance, responds to comments and questions. Manages document review and approval to meet project timelines.
• Directs changeover activities with assistance.
• Exercises judgment within generally defined procedures and practices to determine appropriate action. Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems. Presents a potential solution to management/senior personnel and with assistance creates an implementation plan.
• Applies knowledge, experience and technical skills to understand specific site objectives, to provide support to Production initiatives, to execute systems and procedures efficiently and compliantly, evaluates systems for improvement potential. Works, within established systems to improve Good Manufacturing Practices (GMP) compliance.
• Works on problems of moderate complexity, where analysis of situations requires evaluation of several factors.
• Works under general supervision. Follows established procedures. Decisions are reviewed for soundness of technical judgment.
• Coordinates activities of sub group and actively works under other sub-groups. Provides technical direction and training to less senior personnel.
• Frequently interacts with subordinates and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.

Qualifications

• Bachelor's Degree or equivalent required.
• At least 5 years' experience in all aspects of manufacturing/production processes with good writing skills.
• Knowledge of media/buffer preparation, cell culture or purification of biological drugs is required for specific biologics sites.
• Computer and scheduling proficiency.
• A working knowledge of safety, quality systems, and current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility is required. Familiarity with pertinent regulatory filings. Proficiency with tech transfer process and familiarity with equipment and facilities validation.
• Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner. Effectively work in a team environment. Maintain high level of energy and professionalism on the job. Build effective working relationships with customers, co-workers, cross-functioned groups, and management.