Head of Manufacturing

Chesham, England, United Kingdom | Product Development | Full-time | Fully remote

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Lightpoint Medical is an innovate medical device company dedicated to improving health outcomes for cancer patients through image-guided surgery. The company’s products address the pressing medical need for better tools to detect cancer during surgery in order to improve clinical outcomes and reduce healthcare costs. At Lightpoint Medical we're building a world-class team to transform the practice of cancer surgery. We hire trailblazing professionals who want to make a meaningful impact. If you think this is you, join us now.

Purpose of the role:
Strategic and tactical responsibility for implementing medical device manufacturing strategy and strategic operational goals to meet expectations for product quality, cost and delivery, maximising efficiency, optimising production levels and driving operational excellence.
Work closely with internal and external key stakeholders, regarding technical support for activities, striving for best-in-class medical device products and business practices to deliver to the customer’s expectations, managing teams and projects across the business.

Manage and oversee outsourced drug product development and manufacturing including technology transfer, analytical development, validation, clinical/commercial manufacturing, supply chain, and logistic

Provide clear leadership and vision, inspire and motivate staff to achieve excellence and mentor them as they develop new skills.
Drive Key Performance Indicators across all areas of the Manufacturing function to ensure that all projects are delivered on cost and on time to the highest quality standards.

Skills and Attributes:
• Proven leadership and management skills with the ability to optimise team performance and development
• Excellent relationship management skills with the ability to engage, negotiate and manage key stakeholders and suppliers
• Strong and confident negotiator with the ability to negotiate at all levels
• Excellent communication, interpersonal and influencing skills
• Excellent analytical and problem-solving abilities
• Results orientated with ability to plan and deliver against project deadlines
• Commercially and financially astute with experience of managing budgets
• Resilient, self-motivated and able to work well under pressure

Qualifications and Experience Levels:
• Demonstrable experience of leading a manufacturing function with a proven track record in strategic manufacturing leadership delivering effective manufacturing strategies, policies, processes and systems
• At least 5 years of experience in pharmaceutical CMC development
• Strong working knowledge of cGMP and regulatory requirements for drug product development and commercial manufacturing
• Ability to add value, reduce costs and make business improvements
• Experience with radiopharmaceuticals is desirable but not essential

Key responsibilities
Strategy and Development:
• Create and implement best practice manufacturing vision, strategy, policies, processes and procedures to aid and improve business performance
• Ensure that manufacturing strategies and processes are in place to meet business objectives and operational needs in terms of price, quality and delivery targets and which enables the company to function and compete effectively in the market
• Evaluate the challenges faced by the business and take action to mitigate risks and develop opportunities
• Take ownership of the manufacturing policy, guidelines and any associated documents
• Develop and manage internal drug manufacturing processes and quality controls

General and Task Management:
• Lead, develop and implement variable cost productivity programmes across all areas of responsibility
• Develop phase-appropriate pharmaceutical project plans. Manage plans in compliance with cGMP and regulatory requirements
• Develop and manage master production schedule and operations budgets for products to directly support and ensure that the product is delivered to agreed cost, quality and timelines
• Operate a process for safe selection of external contractors. In conjunction with the Quality team ensure all external maintenance contracts are regularly reviewed to ensure best value
• Provide design for manufacturing input at early stages in the new product development process, coordinating with and supporting the new product development team to implement new and revised designs and developing effective processes to ensure manufacturability of product while maintaining quality, safety and environmental standards and achieving cost targets
• Manage the accurate and on-time introduction of new products
• Support project management to cross functional activity required for project execution
• Ensure that Environmental, Health and Safety, manufacturing and quality standards and procedures are adhered to

People Management:
• Provide leadership to departments under control and coach, mentor and develop direct reports and manage a high performing team that delivers continuous improvement, added value and cost reductions
• Work with the operations team to translate company strategy into specific annual performance goals and departmental objectives including KPIs, and to track them
• Complete regular performance reviews, manage attendance, holidays, disciplinary issues and procedures as appropriate

Financial and Budget Management:
• Input and hold responsibility for manufacturing budgets
• Prepare the annual Manufacturing budget and forecasts and all Capital Expenditure proposals as well as ensuring compliance with legal standards.
• Manage the budget from identification to completion of projects

Relationship Management:
• Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
• Proactively work with CMO to incorporate best practices into the manufacturing environment
• Report on Manufacturing activities on a regular basis to the Senior Management team, ensuring accurate and timely reporting of the relevant Key Performance Indicators
• Work collaboratively, negotiate, and engage with key stakeholders to facilitate delivery and compliance with the manufacturing strategy
• Communicate with stakeholders the impact of technology change and potential effects on supply. Recommend solutions without compromising quality or service while optimising cost
• Contribute to new business initiatives and projects and review and communicate the impact on manufacturing activities

Lightpoint’s close-knit and dedicated staff members are welcoming and friendly and we offer a fast-paced yet flexible working environment. Staff benefits include performance-based tax-advantaged stock options, company pension with matched contributions, income protection and life insurance, annual healthy living allowance, a generous holiday policy and flexible working hours.