Position Details

The Virus Production Manager is an integral part of our Virus team responsible for supervision and leadership of all production activities in the Virus Production department.  Provide administrative and technical support in areas of responsibility as well as communication and coordination of activities with other departments in a fast-paced environment.  Manage scheduling in a manner that supports fulfillment of customer orders within the shortest possible throughput time while maintaining high quality standards.  Monitor all equipment to ensure maintenance is current to avoid downtime.  Ensure all staff are properly trained and competent in pertinent laboratory and safety procedures.  Must possess experience and understanding of/with aseptic technique, autoclave sterilization, good documentation practices, and aseptic processing.  Follows all company protocols, recommends and updates as necessary, and seek continuous improvement in areas of responsibility. 

Key Responsibilities

Coordinate and schedule orders in the most efficient manner with consideration of overall production demands and changes communicated from field personnel. Hire, train, motivate, coach, and develop staff for growth and advancement. Perform semi-annual and annual reviews of all direct reports. Interface with other department managers and personnel to coordinate activities and resolve issues. Continuously monitor material inventory and order as needed. Troubleshoot production problems, document findings, and implement solutions to resolve problems. Maintain equipment calibrations and associated documentation. Review and manage documentation for production records and SOP’s to assure all are current and align with production processes. Write new records/documents as required. Participate in annual review of all relevant Outlines and Special Outlines. Supervise and train lab techs on proper aseptic technique/laboratory procedures. Requisition materials for the department as needed and inventory of materials/bulk virals to assure accuracy and that all necessary transactions are completed. Review of all production records for accuracy and completeness prior to submission to QA. Work in aseptic lab to support production demands. Efficiently manage virus scheduling so that throughput times/quality standards are maintained.

Key Competencies

Skills

Education & Experience

 Education:  Bachelor’s degree or above in a related discipline.  Will consider extensive experience in biological manufacturing in lieu of degree. Three to five years of experience in biologics industry and a minimum of two years in a leadership role.  Prefer experience in virus production. Some knowledge of bacterial fermentation and formulation/filling operations desired.

Language Skills:  Ability to read, analyze and interpret in the English language; correspondence, general business reports, professional journals, technical procedures, and good organizational and writing skills necessary to track and document results/reports. Effective interpersonal skills with a diverse group of individuals at all organizational levels. Strong math skills to calculate volume measurements, conversions and dosages.

Reasoning Ability:  Ability to listen and interpret a variety of instructions furnished in written, oral, diagram, or schedule form.  Ability to define and solve practical problems, collect data, establish facts and draw valid conclusions.  Ability to use Microsoft Office, including Excel and Word.

Physical Demands: Lift 50 lbs. up to shoulder and be able to maneuver carboys up to 110 lbs with mechanical aid.  Must be able to move from place to place in all areas of production.  Frequent repetitions of bending, twisting, lifting, wrist and shoulder movements.  Requires good eyesight for calibrations and hand/eye coordination when viewing glassware, measuring, and filling.

Work Environment:  Office work and cleanroom manufacturing laboratorie s.

Physical Requirements