Director, Manufacturing Project and Product Management

Overview
Director, Manufacturing Project and Product Management at Kyowa Kirin International plc Marlow, UK WE PUSH THE BOUNDARIES OF MEDICINE. LEAPING FORWARD TO MAKE PEOPLE SMILE At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most.

We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose The Director of Project & Product Management (P&PM) provides senior leadership within CMC and associated organizations, responsible for driving the maximisation of the value of development candidates and commercial products through the development and execution of comprehensive CMC strategies across the product lifecycle Responsibilities
Key Responsibilities: Lead cross-functional and cross-regional CMC project teams, ensuring effective planning, coordination, and execution of CMC strategies across all product lifecycle stages Establish, approve, and govern integrated CMC development strategies, action plans, and timelines for projects and products under the P&PM team’s responsibility Oversee the timely execution and delivery of CMC and related functional milestones across multiple projects and products, ensuring consistency, quality, and prioritisation at the portfolio level Provide strategic leadership and guidance on CMC development direction, enabling global teams to adapt plans proactively in response to scientific, technical, regulatory, or business changes Monitor portfolio-level progress of CMC strategies and execution, ensuring optimal outcomes, value maximisation, and efficient resource utilisation across projects and products Drive cross-functional and cross-regional collaboration to resolve complex issues, align stakeholders, and support integrated, timely, and well-governed decision-making Oversee proactive identification, assessment, and management of CMC-related risks at both project and portfolio levels, ensuring robust mitigation strategies and appropriate escalation to governance bodies Ensure that multiple strategic options are developed and presented to top management with clear articulation of cost, speed, risk, and value impact to support informed decision-making Oversee budget strategy, planning, submission, allocation, and expense monitoring across the portfolio Strengthen CMC governance and initiatives by defining and implementing organisational strategies related to operating model design, OPEX optimisation, and departmental policies Develop and support CMC Leads and P&PM team members to strengthen their ability to define, develop, and execute effective CMC strategies while fostering future leadership capabilities Qualifications
Position Requirements Significant experience in the biopharmaceutical industry, with prior experience as technical/functional team lead (DS, DP, Formulation, Analytical, et al) Experience in project and program management across CMC and partner functions Experience leading global cross-functional teams is preferred Experience with pharmaceutical DS and DP manufacturing and analytical development, validation, scale up, technology transfer, and global regulatory requirements Experience in preparation and negotiation of development or commercial agreements focused on pharmaceuticals Experience with global Change Controls Experience with multiple dosage forms (sterile injectables, pre-filled syringe, auto-injector, gene and cell therapy, tablets, capsules, syrup, etc.) and manufacturing processes Experience with oversight of supply chain processed for biologics, small molecule, secondary packaging, cold chain products Experience working effectively with CDMOs/CROs, vendors, suppliers – building and maintaining successful partnerships Experience with North America, EU, Japan and Global regulatory filings/submissions is desirable Kyowa Kirin International is an equal opportunities employer.

No agencies please.