• Works with cross functional team to facilitate NPI process fit; including batch record review, assistance with area engineer to ensure process fit within BU3 manufacturing suites, work with Tech transfer to produce standardized and efficient clinical batch record. Supports established project campaigns as needed.
• Support business area process validation activities when needed to ensure area documentation aligns with quality documentation for process validation.
• Schedules work tasks, without assistance, to support project and campaign timelines.
• Reviews documents with diverse scope and complexity. Manages document review and approval for the operations group to meet project timelines.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Tracks ongoing problems and gathers information for analysis. Uses analysis to develop solutions to broad-level problems. Presents potential solutions to management and senior personnel, and with limited assistance creates an implementation plan. Develop BU3 metrics and help establish meaningful KPIs to identify and enable continuous improvement in tech transfer and new product introduction.
• Applies knowledge, experience, and technical skills to understand production objectives and evaluate potential changes, implement production initiatives. Executes systems and procedures efficiently and compliantly and evaluates systems for improvement potential. Develops and uses standard practices to ensure inter-group consistency.
• Coordinates activities of subgroup 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.

•Bachelor’s Degree or equivalent required.

•At least 5 -8 years’ experience in all aspects of manufacturing and production processes.

•Knowledge of media and buffer preparation, cell culture and purification of biological drugs is required; Computer expertise and scheduling proficiency; In-depth knowledge of safety, quality systems, and current Good Manufacturing Practice is required; Expertise with tech transfer process and familiarity with equipment, facilities validation, and regulatory filings.

•Must be flexible to handle multiple tasks including ability to handle pressure in a professional and positive manner; Effectively works in a team environment; Maintains high level of energy and professionalism on the job; Builds effective working relationships with customers, co-workers, cross-functioned groups, and management.

•Uses problem solving skills when working on complex problems, where analysis of situations requires an in-depth evaluation of various factors.

•Uses discretion and works under general supervision; Follows established procedures. Decisions are reviewed for soundness of technical judgment. Independently decides when to make minor adaptations or modifications.

•Coordinates the completion of daily operational activities across a unit or sub-unit. Decisions, recommendations and actions contribute to the development of suite schedules and personnel allocation.

•Provides technical direction and training to less senior personnel; Coordinates activities of sub-group and actively works with other sub-groups. Acts as advisor to unit or sub-unit becomes actively involved as required. Provides technical direction and training to less senior personnel. Participates in technical investigations and provides on the floor technical expertise; Provides a motivational and team building atmosphere. Acts as a mentor.

•Frequently interacts with subordinates or functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc. Regularly discusses progress, problems, and proposed solutions with colleagues and senior personnel.

•Detailed understanding of current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility. Able to make recommendations for improved compliance at plant level. In-depth knowledge of pertinent regulatory filings.