Manufacturing Supervisor, Downstream (Night Shift)

Position Overview

The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations.  This individual will supervise a team of employees directly or indirectly in these production process units.

Job Description

Operational oversight of the following systems dependent upon assignment:

 

Upstream Unit:

• Single-Use Cell Culture Vessels/Bioreactors up to 2000L
• Bacterial Fermentation Culture Vessels up to 2000L
• Alpha Wasserman Continuous Flow Centrifuges
• Disposable Magnetic Mixing Bags and Totes
• Cell Expansion and Propagation
• Banking/Cryopreservation of Cell Lines and Viruses
• Hyperstack, Cellstack and other adherent cell technologies 
• Plate counting, microscopic examination
• Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation

Downstream Unit:

• Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF) Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration.

• Medium to Large-scale Chromatographic systems (ÄKTA)
• Pre-Packed Columns from 1L to 100L
• Single use mixing systems (Pall & GE)
• Single Use connectivity types such as GE DAC and Colder AseptiQuik
• Plate counting, microscopic examination
• Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation
• Bulk filling
• Aseptic process simulation and drug product filling

Solution Preparation Unit:

• Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs

• Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs
• Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures
• Integrity testing of filters

Essential Functions Include:

• Responsible for supervising daily manufacturing activities and staff, including hiring, performance evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc.
• Responsible for implementing project safety and quality assurance programs
• Execution of SAP functionality for batch close out and generating SAP reports as required. 
• Develop, write, and review Standard Operating Procedures, Buffer Formulation Records and Batch Production Records (BPRs).
• Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations.
• Lead deviation resolution and closure with subject matter expert and quality teams.
• Responsible for tracking CAPAs to closure.
• Provide input and support to R&D functions during development and scale up activities as necessary.
• Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes.
• Ensure an adequate supply of materials available; ensure all materials for project are procured prior to production.
• Maintain the confidentiality of proprietary company information.
• Responsible for continuous improvement in areas of responsibility.
• Maintain an effective working relationship with others.
• Perform all other duties as assigned.  

 

Required Skills & Abilities:

• Demonstrated leadership, coaching and mentoring skills.
• Demonstrated experience in training others to perform and maintain cGMP standards
• Excellent skills with Microsoft Office applications.
• Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. 
• Must be able to work alternative shift hours and weekends as required.

• Excellent self-discipline and attention to detail.
• Advanced math and computer skills.
• Must have exceptional planning and organizational skills, excellent oral and written communication skills, and be proactive in process interfacing with colleagues in various roles and functions throughout the manufacturing facilities.

• Demonstrated ability to work with teams and collaborate with others.
• Excellent problem-solving skills.

 

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully

perform