Senior Director, R&D Project Management Head, Established Products/CMC
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The incumbent is the Global RDPM leader for EP/CMC project managers, supporting the EP/CMC portfolio with a current footprint covering four sites (Kankakee, IL; Broadmeadows, AUS; Bern, Switzerland; Marburg, Germany), each having a site lead (direct report). The scope of this portfolio may include process, analytical, formulation and/or supply chain enhancement projects across all CSL production platforms. Special focus will be given to products on the plasma supply chain given their technical and operational interdependencies. In this role, the incumbent will provide senior leadership, direction, and consistent, efficient business processes to drive RDPM staff to effectively execute this portfolio in alignment with business priorities and in support of the R&D business objectives.
- This position reports into the VP, RDPM
- Reporting into this position are the EP/CMC site leaders at Kankakee, Bern, Broadmeadows, and Marburg. Additional manufacturing/CMC sites with R&D infrastructure and with an RDPM presence (e.g., Lengnau) could report into this role in the future
Main Responsibilities and Accountabilities:
1. Be the primary and single point of contact and key business partner with E2E Operations/Manufacturing on behalf of RDPM.
- Develop integrated, where appropriate, interdependencies and ways of working to ensure the R&D portfolio of EP/CMC projects are planned, scheduled, resourced and executed in accordance with portfolio prioritizations.
- Implement, evolve and maintain transparency, reporting and integration of project and portfolio prioritization and Governance decisions – for both E2E and R&D - to ensure alignment across the CSLB business.
2. Develop innovative, new ways of working to support the development and evolution of the EP/CMC PM organization to support the 2030 R&D Strategy
3. Be the lead RDPM contact for and/or member of PCSC/PCP (E2E Governance) and global operations/LCM-oriented strategy and planning forums. Provide strategic input into committee decisions and priorities representing R&D and RDPM EP/CMC sites/staff
4. Guided by strategic business priorities articulated by senior management, oversee allocation of RDPM resources/capacity to this portfolio across sites
5. Anticipate future resource demands from the EP/CMC portfolio; build solutions for timely execution of such meeting business needs and in consideration of any business constraints.
6. Specifically guide cross-project acceleration/deceleration/interdependent decision making through collaboration and direction given to RDPM EP/CMC site heads and respective staff. Develop relevant KPIs for business performance and generate metrics to evaluate performance.
7. Optimize and standardize the service model provided by RDPM for EP/CMC-type projects to be consistent with high-value creation and agreed roles/responsibilities with other functions and site personnel
8. Optimize the development of EP/CMC budgets; monitor and manage budgets to within 5% of annual, approved budgets (project and non-project budgets)
9. Bring more clarity to the current and future EP/CMC portfolio, resource demands, required skills, capabilities, financial/budgetary responsibilities, business processes and technologies
10. Work with RDPM Project and Portfolio Operations and site leaders to optimize and install CMC/LCM-relevant PM methodologies
11. Develop/install training and talent development plans for EP/CMC-focused PM Staff ensuring individual development plans, and in alignment with the broader RDPM skills development and capability expectations
Position Qualifications and Experience Requirements: .
- Undergraduate science/business degree in relevant discipline essential, preferably with post-graduate qualifications
- Post-graduate qualifications in business administration or related field preferable
- 10 years or more working experience in the Pharma and/or biotech industry in a CMC-focused R&D or production environment
- Experience managing complex, multi-year projects and portfolios required
- International, global experience required
- People management experience required; experience managing people managers preferred
- Sound scientific understanding of the drug development process and associated risk
Essential Skills, Knowledge & Attributes
- Must demonstrate advanced understanding of biological manufacturing processes; Experience with plasma-derived production preferred
- In-depth knowledge in the drug development and manufacturing processes for pharmaceuticals (CMC, Quality, Product Development, Process Development, drug product/Manufacturing Life-Cycle-Management, Regulatory Affairs) with strong technical and business acumen
- Experienced People Manager with proven ability to develop talent and achieve results through teamwork and leadership of others, streamlined execution, and innovation in a matrix Business Unit environment, particularly in a Global business.
- Demonstrated ability to think strategically, create innovative strategies, manage ambiguity and able to anticipate future trends and consequences
- Proven networking, stakeholder management and influencing skills and ability to share knowledge and experience amongst colleagues
- Strong negotiation skills and is able to identify and engage internal and external expertise as needed
- Demonstrated ability to drive change, create positive working environment, influence senior leadership and inspire/develop people
- Expertise in all phases of Project Management, Initiation, Planning, Execution, Monitor/Control, Closeout.
- Demonstrated experience in developing, managing and controlling project and non-project (e.g., department) budgets, timelines and scope documents.
- Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters
- Strong verbal, written and presentation skills and excellent written and spoken English
- Strong analytical skills