VP – Manufacturing

The VP Manufacturing will lead and direct ProKidney’s cell therapy manufacturing activities to achieve key milestones and meet business objectives for the Winston-Salem manufacturing site. Responsibility for ensuring ProKidney products are manufactured meeting or exceeding requirements for safety, quality, reliability, on-time and within budget.  This individual will ensure a high degree of collaboration and communication within the team and cross-functionally within the organization. This includes leading key manufacturing value streams (aseptic operations, MSAT, aseptic cleaning, training, scheduling functions), strategic support of the site-wide operating and expansion plan and enabling a high degree of employee engagement at the site.

The role is a member of the Site Leadership Team providing leadership, mentoring, and guidance to achieve site operational objectives, implementation of process improvements and complete strategic regulatory/cGxP initiatives. 

Main Responsibilities and Accountabilities:

• Lead manufacturing activities to deliver on strategic plan objectives and departmental goals for safety, quality and reliability. Ensure planned production targets are met. Ensure, stable, ongoing operations for cell therapy manufacturing are established:

• Define and deliver on key objectives for the manufacturing department. Provide clear directions for execution.

• Responsible for identification and acquisition of top manufacturing talent.

• Develop department competencies via implementation of a comprehensive training program with a strong emphasis on aseptic GxP processing and technical support.

• Establish and sustain employee engagement by creating a collaborative, performance-focused culture. 

• Ensure effective utilization of personnel, equipment and material to meet both budgetary targets and product quality, compliance and on-time supply objectives.

• Promote cross-functional collaboration to ensure that effective quality, maintenance, training, and validation activities are performed to established standards.

Identify and implement continuous process, productivity, and cost improvements

• Support continuous improvement initiatives to ensure ProKidney products meet operational, regulatory and business plan targets.

• Support financial budgeting/tracking/analysis processes and strategic financial initiatives

• Identify opportunities for cost reduction and continued productivity improvements.

Promote Manufacturing Team and Site Leadership

• Provide site-based leadership to manufacturing team.

• Identify and set key department objectives and provide clear direction for execution.

• Build and maintain employee engagement by creating a work culture of sustainable, compliant execution

• Enable a collaborative environment in which individuals/teams excel and continuously improve.

• Provide mentorship to direct reports. Identify and support personnel development initiatives.

• Ability to navigate through ambiguity and rapid growth and manage through change.

• Adapts departmental plans and priorities to address resource and operational challenges.

• Outstanding communication skills (verbal and written) to collaborate with Senior Management in a dynamic environment.

• Must be capable of motivating others, creating a positive work climate where inter-departmental collaboration, coaching and performance feedback are continuous.

• Natural ability to be organized in how you think, communicate, and conduct your work.

• Proven ability to quickly formulate and communicate concise, logical, fact-based information and make recommendations to internal and external stakeholders.

• Ability to adapt to rapidly changing environment and priorities while maintaining existing operations.

• Consistently acting and leading with personal accountability for the safety of the team and the entire organization. Must know job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.

• Capable of clearly assigning objectives, clearly setting and measuring and monitoring progress, marshaling resources and handling competing priorities.

• Experienced at establishing clear directions, leading others and bringing out their best

• Perform other duties as assigned.

Minimum Requirements

Education

• B.S. in Science or related Engineering field required. Advanced degree preferred.

Experience

• 15+ years of biopharmaceutical industry experience

• 10+ years’ experience leading GMP, clinical and commercial programs, preferably with 3+ years of cell therapy production experience. 

• 10+ years in progressively senior management roles leading structured, technical groups

Skills

• Ability to work with Senior Staff members and colleagues to develop and meet company goals.
• Strong level of business acumen. Ability to collaborate with other departments.
• Demonstrated experience in budgeting and understanding of business value drivers.

• Experience in leading change in a large, regulated manufacturing environment.

• Regulatory inspections experience - with FDA and/or EMA preferred

• Strong influencing skills / communication skills / team building skills

• Highly motivated / Results Driven / Robust and resilient / proven technical competency

• Hands-on Operational Excellence experience