Production Services Manager - Overnight Shift

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Manager of Production Service will provide support to the Manufacturing Operations by leading the production services team in operational and continuous improvement activities. The focus of this position is to ensure facility cleaning is performed, materials are stock and staged for use in unit operations, solution formulations are manufactured and released for use in unit operations and startup / breakdown operations occur to maintain the production schedule, and monitoring operations occur during the off shift. Direct reports include Lead (Senior Production Service Associate) as well as Production Service Associates I & II

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

FLSA: ExemptAbzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.