RESPONSIBILITIES

• Lead the manufacturing, warehousing, shipping, and receiving operations for the Navy Yard manufacturing facility. Design and implement the manufacturing organization needed to meet required production targets. Hire and train required staff for the GMP aseptic manufacturing process and warehouse operations. Lead development of required SOPs and work instructions to execute manufacturing and warehouse operations.
• Partner with Supply Chain, Sourcing, Procurement, QA, QC, and Cell MS&T to execute the manufacturing plan to meet clinical (and future commercial) supply needs. Work with planning to schedule personnel and equipment (ie shift patterns, unit operations). Anticipate staffing and facility needs to develop manufacturing plans in support of clinical and commercial growth.
• Design and implement warehouse operations, including staffing needs, receiving/shipping processes, and material kitting processes to support manufacturing.
• Work with Information Technology to identify and implement required manufacturing and warehouse software systems (e.g. electronic batch records, MES systems, warehouse management systems, etc)
• Partner with Process Development/Cell MS&T to identify and transfer new processes into manufacturing. Proactively work with PD to on improving processes. Ensure tech transfer processes are followed, protocols properly executed, and GMP requirements are followed (ie IQ/OQ/PQ activities)
• Ensure proper GMP processes are identified, implemented, and followed for aseptic manufacturing and warehousing.
• Coordinate with QA, QC, and MS&T on any deviation or OOS investigations. Ensure appropriate CAPAs are identified and implemented.
• Work with facilities, maintenance, and calibration to ensure the GMP manufacturing facility (including warehouse) is maintained in an appropriate state of operations to support all manufacturing needs.
• Design and implement appropriate manufacturing and warehousing Key Performance Indicators.

REQUIREMENTS

• 12+years’ experience in cGMP aseptic manufacturing of biologics for clinical and/or commercial use
• B.S./M.S. in Engineering or Life Sciences required; Ph.D. a plus.
• Highly effective people manager with at least 8 years’ experience in managing a manufacturing team and facility in a biotech/pharma company
• Knowledge of GMP aseptic pharmaceutical facility design, commissioning, validation and operation
• Collaborative, team-based approach to working with colleagues cross functionally to drive innovation and continuous improvement
• Ability to manage multiple projects in a dynamic situation while maintaining the ability to troubleshoot and ‘think outside the box”
• Excellent oral and written communications skills and computer literacy with Microsoft Office
• Strong interpersonal and communication skills (both spoken and written)
• Strong relationship building skills—collaborates effectively with others, both internally and externally.
• Takes accountability, develops and implements solutions to problems—does not blame others
• Excellent leadership skills—builds and leads high performance teams, motivates, develops, coaches and inspires others.
• Respects and values diverse thinking; works effectively cross culturally
• Effective negotiation skills with ability to employ different styles and/or strategies to influence others
• Proven ability to manage multiple, sometimes complex and competing priorities to effective and efficient conclusion.
• Ability to operate both strategically and tactically—understands and communicates the big picture while willing to roll up sleeves to get work done
• Comfortable with ambiguity—able to work effectively in an evolving and dynamic environment, with experience developing structure and process to operate efficiently and effectively
• Sense of urgency and ability to work effectively to timelines to ensure delivery of key services, supplies, goals and objectives
• Highly motivated, independent and a self-starter

DESIRED

• Experience in launching new pharmaceutical/biologic products
• Biologic Process Development Experience
• Experience with cell and gene therapy manufacturing
• Experience with early stage and late stage/commercial pharmaceutical/biotech companies
• Experience starting/standing up a new manufacturing organization
• Strong background working with ERP/MRP/Supply Chain systems and tools