At a Glance
- Tasks: Lead cross-functional teams to drive innovative pharmaceutical projects and strategies.
- Company: Kyowa Kirin International, a caring and inclusive pharmaceutical company.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Join a dynamic team focused on innovation and collaboration.
- Why this job: Make a real difference in patients' lives while pushing the boundaries of medicine.
- Qualifications: Significant biopharmaceutical experience and strong leadership skills required.
The predicted salary is between 51750 - 63250 £ per year.
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.
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.
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.
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 processes 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.
Director, Manufacturing Project and Product Management in Marlow employer: Kyowa Kirin International
At Kyowa Kirin International, we pride ourselves on fostering a culture of teamwork, innovation, and integrity, making it an exceptional place for IT Security Engineers to thrive. Located in Marlow, our inclusive environment not only prioritises employee well-being but also offers ample opportunities for professional growth and development within the pharmaceutical sector. Join us to be part of a dedicated team that is committed to making a meaningful impact on patients' lives while advancing your career in a supportive and dynamic setting.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Manufacturing Project and Product Management in Marlow
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We think you need these skills to ace Director, Manufacturing Project and Product Management in Marlow
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Kyowa Kirin International!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Kyowa Kirin International that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Kyowa Kirin International!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Kyowa Kirin International, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Kyowa Kirin International
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Kyowa Kirin International that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Kyowa Kirin International’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
