Production Services Manager

Salary Range: 135000 to 155000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Manage large volume liquid (buffer/media) manufacturing in support of Upstream Cell Culture and Downstream Purification operations
• Manage schedule use for production equipment with single-use materials as it relates to buffer and media preparations, including weight and dispense. 
• Manage schedules to maintain daily, weekly, and monthly cleanings of the cleanroom and surrounding controlled areas, including floors, walls, ceilings and equipment.
• Manage batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. 
• Manage, lead, mentor, and train all manufacturing employees in execution of buffer and media preparation.
• Manage and ensure documentation/verification of task completion is performed in accordance with cGDP, SOPs and Batch Records. 
• Set up and use equipment in accordance with established practices. (i.e. RTP, STR, Production Bioreactors, AKTA systems, Depth Filters and Pods, Viral Filtration, and UFDF)   
• Oversee specifically assigned projects, to include monitoring project timelines, ordering supplies, and communication of project status to senior management.
• Network with MSAT, Manufacturing, and Quality organizations to establish a reliable state of process control
• Participate in technical transfer and implementation of media and buffer preparation strategies.
• Oversee activities involving buffer mixers, filtration systems, raw material management and intermediate solution delivery
• Draft, review and approve SOPs, master batch records, and other cGMP documentation
• Prepare technical reports, summaries, protocols, batch records and quantitative analyses as needed.
• Change owner for implementation or revision of equipment, documentation, and material specifications
• Propose implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success
• Develop effective working relationships with internal partners
• Represent departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups, as needed.
• Provide input and feedback on performance of production associates.
• Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena strategic goals
• Adhere and train staff on appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms.  
• Ensure documentation/verification of task completion is performed in accordance with cGDP, SOPs and Batch Records. 
• Forecast work scheduled activities in support of production schedules. Support floor operations for multiple projects simultaneously. 
• Monitor processes and results and troubleshooting issues as they arise to ensure process success.
• Instruct associates through process and workflow improvement initiatives.
• Enforce cleanroom standards for cleanliness and order
• Review GMP records for completeness, accuracy, and compliance daily in conformance with regulatory requirements.
• May cross-train on various tasks supporting Upstream and Downstream cGMP manufacturing to support overall success of the Biologics group
• Operate to the highest ethical and moral standards
• Comply with Abzena's policies and procedures
• Communicate effectively with supervisors, colleagues and staff
• Participate effectively as a team player in all aspects of Abzena's business
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
• Perform other duties as assigned

Qualifications

• BA/BS or MA/MS degree that included laboratory work in biology, microbiology, chemical engineering or related field.
• Minimum 6 years of experience in manufacturing operations, preferably in a GMP environment.
• Experience leading and developing associates, minimum 2 years of experience
• Experience organizing workload, oversee workload of direct reports, and relevant resource requirements.
• Experience in leadership duties, including time management and planning.

Physical Requirements

• Physical ability to walk, stand and sit for extended periods of time.
• Ability to work in an office setting where sitting and computer usage would be the norm.
• Use arms, hands and fingers to handle, feel or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus