Senior Associate, Manufacturing

Required

• Bachelor’s Degree or equivalent required.
• 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 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.