Manufacturing Supervisor, Upstream - 3rd Shift

• Supervises employees in the upstream manufacturing team. 
• Responsible for the Bill of Materials for the upstream manufacturing process.
• Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include: evaluating performance, hiring, training and developing staff; planning, assigning daily tasks; rewarding and disciplining employees; addressing complaints and resolving problems.
• Responsible for maintaining equipment and raw materials inventory. 
• Assist in development and creation of the upstream process for GMP manufacturing.
• Monitor upstream operations (including trouble shooting and diagnosis of instruments, equipment, process, etc.) 
• Responsible for upstream manufacturing equipment/labware/assemblies (includes biological safety cabinet, incubator, bioreactors, harvest filtration, harvest centrifugation, autoclave/sterilizer, bench top meters (pH/conductivity/osmometer), etc.) in accordance with current good manufacturing practices (cGMP).
• Based on business needs, there will be some cross training to support downstream operations (includes filtration skid, chromatography skid, viral filtration skid, TFF skid, Bulk fill, Freeze/Thaw etc.) in accordance with current good manufacturing practices (cGMP). Upstream Manufacturing Supervisor will coordinate with downstream Manufacturing Supervisor during these periods. 
• Provide data and other content for drafting and presentation of technical reports.
• Responsible for timely completion of quality systems (including critical work orders, document change requests, change control, deviations, corrective action preventative action (CAPA)).
• Responsible for the creation and revision of standard operating procedures, batch records, part numbers, specifications, etc.
• Support Process Development activities including small scale bioreactors for clone selection, clarification of harvest, and process transfer to GMP production.
• Supervise the chemical weighing and solution preparation for GMP manufacturing.
• Maintain inspection readiness for GMP facility (General cleaning of GMP work areas, equipment, etc.) including waste disposal.
• Perform technical training for staff (including hands-on and class-based training)
• Assist CMC team with technical transfer activities. Identify and implement equipment and process improvements.
• Maintain clean room work areas (including floors, benches, bioreactors, chromatography skids, etc.) waste disposal, lean manufacturing and good manufacturing practices (GMP)/compliance.

• BS degree in life or physical sciences or more than 8-years of relevant experience.
• Minimum 5 years of GMP biopharmaceutical manufacturing.
• Proven ability to effectively manage multiple projects with strict timelines.
• Proven decision-making skills.
• Proficiency of all upstream equipment and processing (cell banking activities, scaleup activities, bioreactors, harvest centrifugation, harvest filtration, solution preparation equipment (laminar air flow hood, agitator mixers, bench top instruments) are essential for this position. 
• Attention to detail and accurate record keeping and documentation is mandatory in this position. 
• Teamwork and communication are key attributes needed for this position. A collaborative attitude and a positive work ethic are key traits for success.
• Flexible work hours as business requires.

Special skills/knowledge:

• Experience in (any or all) technology transfer, validation, filling, and/or facility start-up.
• Hands-on experience with cell culture equipment and related analytical equipment.
• Thorough knowledge of bioprocess validation and associated documentation.
• Management experience and effective communication skills.