Manufacturing Supervisors-All Departments (2008257)

DescriptionThe Manufacturing Supervisor is responsible for the hands-on, daily supervision of GMP manufacturing operations and personnel within a manufacturing suite. The Supervisor will participate in all aspects of personnel management (interviewing, training, coaching, developing, and disciplining) and will be the primary advocate for their staff. The Supervisor will also maintain responsibility for all day to day operations in the GMP Manufacturing suite in which they are assigned.Responsibilities include:•Hands-on supervision and support of Manufacturing staff in the operation of all upstream, downstream, or support equipment to include: autoclaves, depyrogenation ovens, fermentors, centrifuges, homogenizers, filtration skids, chromatography skids, process vessels, etc. •Providing leadership and developmental opportunities to staff. Establishment of strong coaching/mentoring relationship with staff members•Conducting performance appraisals of Manufacturing staff•Serves as the lead trainer on manufacturing processes and all related equipment•Maintaining professional and positive interactions with client representatives•Communication of manufacturing process status and relevant critical data and details to Manufacturing Management, subordinates, and other internal departments•Timely reporting, investigation and resolution of manufacturing deviations, OOTs, CAPA’s, etc. •Writing and revising batch records, SOPs, and solution documents as necessary to ensure compliance to GMPs. Timely review of completed manufacturing documentation (batch records, worksheets, solution docs., etc)•Coordination and supervision of product changeover activities•Personnel scheduling•Providing assistance in troubleshooting manufacturing process issues•Coordination of routine suite and equipment maintenance, calibration, and validation with appropriate internal departments•Demonstration of understanding and adherence to company policies, GMP standards and safety procedures. Maintains a safe work environment for all employees.•Carrying a 24-hour company provided cell phone to respond to urgent issues in real time.~cb~Required Experience•BS in Scientific/Engineering discipline and 5 years experience with large-scale GMP biotech manufacturing processes; or equivalent education, training, and experience, or any combination thereof•Strong knowledge of Manufacturing processes and GMP regulations•Ability to lead, coach and mentor staff•Ability to trouble-shoot process and equipment problems and recommend effective solutions•Ability to work flexible schedules (shift work) and holidays as needed•Good management and organizational skills•Demonstrated written and verbal communication skills•Proficient computer skills (Microsoft Word and Excel)•Strong interpersonal skills•Team player who can excel in a “hands on� entrepreneurial environment