AVP/ VP- Drug Substance Manufacturing

Overall, Purpose of the Role:

As a member of the Manufacturing Operations Management team within Technical Operations at Stelis, this position will be accountable for overseeing all activities in the company's Drug Substance (DS) contract manufacturing network. The incumbent will lead cross-functional teams and support processes and systems to ensure exceptional quality and reliability throughout the external drug substance manufacturing network. This includes developing a CMO strategy, managing the business relationship, ensuring the successful supply of products, and achieving operational and business goals. The position will also lead DS product changes, investigations, process improvement, and risk mitigations.

Key Skills :

Engineering skills for plant improvements Knowledge of utility management planning and organizing skills, Troubleshooting, Fair knowledge of costing, Cost reduction technique, and Operation management.

Primary Responsibility:

• Responsible for the overall performance of the Drug substance CMO business.
• 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 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.
• Contribute to overall business strategy and annual budget process.
• Take ownership of the manufacturing policy, guidelines, and any associated documents.
• Initiate and develop creative and innovative manufacturing processes.

• Responsible for organizing and leading the company's cross-functional teams which work with the CMOs including Quality, Regulatory, Finance, Technical Operations, Legal, Clinical, MSAT, Commercial, and Business Development.
• Lead, develop, and implement variable cost productivity programmes across all areas of responsibility.
• Implement a customer-focused operational culture delivering world-class customer service levels.
• Facilitates the identification, prioritization, planning, and execution of a broad range of medium to complex technical projects. Ensures successful and timely completion of deliverables. Owns planning and execution of technical changes that have regulatory impact.
• Develops and maintains project plans for key DS related deliverables. Leads risk identification and mitigation activities. Proactively identifies and tracks issues and drives their resolution.
• Ensures the CMO executes the production plan to deliver an uninterrupted supply of commercial product. Identifies supply constraints and leads to timely resolution of issues. Monitors production campaigns and reports on CMO's performance against plans.
• Manage Stelis / CMO relationship including negotiation of improvement plans to address performance or contractual issues.
• Ensures CMO project plans are aligned with overall Stelis plans for regulatory filings and other key initiatives.
• Ensures that Environment Health Safety and Quality audits are performed, and mitigation plans are in place for the CMO to comply with terms of agreements, corporate group policy, and local legal requirements.
• Coordinate team activities to optimize the cost performance of the plant through capital investment programmes, optimizing operating working capital usage, and minimizing waste through the development of a continuous improvement culture encompassing lean principles and clear strategic development.
• 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.
• Plan and execute maintenance activity to ensure the plant is kept safe and compliant.
• Drive improvements in reliability for key aspects of machinery by completing reliability studies and identifying best-planned maintenance strategy.
• 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 developing effective processes to ensure manufacturability of product while maintaining quality, safety, and environmental standards and achieving cost targets.
• 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 Local laws.

• 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.
• Establish a strategy and best practices for staff to ensure the achievement of overall business objectives. Work with the Manufacturing team to translate site strategy into specific annual performance goals and departmental objectives including KPIs, and to track them.
• Set department objectives and monitor ongoing progress and performance.
• Ensure strong communication between teams under leadership to facilitate the exchange of information and to implement change and improvements.
• Ensure that the function operates by any health, safety, and environmental policies and procedures to ensure the safety and well-being of staff and visitors.
• Responsible for developing the appropriate organizational structure, resource plans, and culture to support the business objectives and customer deliverables.
• Provide leadership, coordination, and coaching to the team, ensuring they are trained enabling them to achieve the operational and financial metrics within their areas of responsibility and succeed in their roles.
• Complete regular performance reviews, and manage attendance, holidays, disciplinary issues, and procedures as appropriate.

• Review commercial supply and quality agreements. Forecasts CMO budget and gains approval. Controls cost to ensure the CMO Site is within the approval budget.
• 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.

• Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.
• Proactively work with R&D, DP Manufacturing, Engineering, service, and other departments to incorporate best practices into the manufacturing environment.
• Report on Manufacturing activities regularly 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 optimizing cost.
• Contribute to new business initiatives and projects and review and communicate the impact on manufacturing activities.

• Proven leadership and management skills with the ability to optimize 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 the ability to plan and deliver against project deadlines.
• Commercially and financially astute with experience in managing budgets.
• Resilient, self-motivated, and able to work well under pressure.
• Technical mindset.
• An appreciation of and an ability to positively resolve issues arising from different cultures.
• Handling Audits & Regulatory Compliance management.

• 20 + years of work experience with BTech / MTech in Biotechnology/ BE/ME Chemical, MBA – (preferably Masters in a relevant engineering /manufacturing discipline or equivalent).
• Experience working with Contract Manufacturers is required with overall knowledge of biologics Drug Substance commercial manufacturing in a cGMP-regulated environment. Monoclonal Antibody Experience is highly desired.
• Previous experience in technology, quality, and/or supply chain roles is preferred.
• Certification in Project Management (i.e. PMI certification) or additional relevant management training is preferred.
• Previously worked with the cGMP-regulated environment including relevant US/EU regulatory and quality requirements, practices, and standards.
• Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams.
• Demonstrable experience in leading a manufacturing function with a proven track record in strategic manufacturing leadership delivering effective manufacturing strategies, policies, processes, and systems.
• Ability to add value, reduce costs, and make business improvements.
• Proven project management and build quality experience.
• Experience of operating and influencing at a strategic level.