Executive Director Plasma Product Development

About CSL

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!

Job Description

The Executive Director of PPD within R&D provides leadership for R&D Plasma Product Development programs and Kankakee Facility for new product development programs, life cycle management projects, and technical support of the manufacturing operations including processes, equipment, and products. While located in Kankakee, the candidate will be required to operate both locally as well as globally. The successful candidate will be responsible for the global PPD pilot plant strategy that includes management responsibilities, program support, facilities oversight, and expansion plans. In addition, he/she is integral to the development of global strategies and initiatives for Global Plasma Product Development as it relates to both the global R&D project portfolio and the Kankakee site initiatives. The incumbent is expected to work globally with colleagues with similar responsibilities, plus global pathogen safety and CMC to develop project with global implications and ensure strategy and resource alignment across global projects. In addition to PPD, the successful candidate will serve as a senior member of the Kankakee leadership team supporting local initiatives, programs, and products.

Main Responsibilities and Accountabilities:

Strategic Direction:

• Develop concepts and oversee projects related to new product development, including design of experiments and comparability analysis. Ensure to include concepts of QbD and ICH 8, 9 and 10.
• Participate in the development of PPD R&D long-term, global strategies for new and LCM programs and align objectives, resources, project plans and timelines accordingly.
• Execute and oversee the development and coordination of projects related to CSL strategic business planning and product life cycle management plan for Kankakee projects as well as global programs.
• Manage/develop the strategic planning for the PPD pilot plant network including key areas of capital management, site harmonization, planning, compliance, and harmonized business/operational processes.

Global Pilot Plant:

• Responsible for the development and oversight of a long term global pilot plant strategy for PPD
• Is the leader for all aspects of pilot plant strategy and management. Ensures pilot plant capabilities including compliance at each site are harmonized to a global set of standards.
• Ensures all pilot plants are managed to meet matrixed project timelines and to achieve key milestones for the R&D project portfolio.

Tech Ops Support:

• Provide leadership, consultation, technical advice and as necessary manage resources to resolve deviations, conduct investigations, implement process improvements, etc. As needed, oversee the troubleshooting of manufacturing process related problems both locally and sometimes globally, provides technical support and expertise to manufacturing departments, and provides expertise to support the marketing and distribution of biopharmaceutical products.
• Directly and indirectly oversees the technical transfer in the U.S. and abroad using sound scientific strategies as well as implementing regulatory strategies for managing changes to processes or facilities to minimize impact on global product release. .

Regulatory:

• In collaboration with GRA, develop regulatory strategy for managing changes to processes or facilities to minimize impact on product release. Assure awareness of pertinent regulatory requirements exists within R&D groups at Kankakee.

Development:

• Oversees the direction, development, evaluation, and implementation of LCM projects targeting increased yields, reduced cost and/or improved compliance for the site products.
• Initiate as required new product research projects in collaboration with Global R&D groups. Oversees the staff responsible for the direction, development, and implementation of these projects.
• Oversees the staff responsible for the development and validation as required of new analytic technologies to enhance cycle times, characterization, and strengthen process robustness
• Accountable for the development of leadership and technical talent within their respective remit site as well as the broader global PPD/R&D function. Responsible for all aspects of succession planning for Executive Director position as well as other positions within line management. Leads the R&D team per CSL values as defined in "Driving Performance" and " Building Productive Teams"

Compliance:

• Accountable for the compliance in all relevant areas and associated training of Kankakee R&D staff, both from local and global levels.
• Oversees the staff responsible for the preparation of necessary documentation and reports in compliance with cGXP, and in support of licensing activities for new and existing products.

Leadership:

• Serve as local R&D Kankakee Site leading, including the local contact at the site for site related topics and provide site support, coordination and communication for all R&D departments at the Kankakee Facility.
• Provide a global mindset to contribute to company PPD Strategy through participation on the Global PPD Leadership Team. Work closely with the Sr. VP PPD and other PPD colleagues to maintain an effective Global PPD organization. Interact and communicate with various site leaders on cross-site projects to ensure alignment and execution
• At the strategic level, manage the activities of the PPD Kankakee group including headcount and budgets (OPEX & CAPEX). Should be able to influence others outside of direct management lines to achieve local and global objectives.

Creating the Future:

• Works to influence others to accept the job functions views/practices and agree/accept new concepts, practices and approaches.
• Serves as a role model for CSL's Values (Customer Focus, Innovation, Integrity, Collaboration, Superior Performance)
• Understands CSL's mission, vision, and strategy and develops action plans to drive strategy execution
• Is dedicated to fulfilling the needs of internal and external customers and stakeholders
• Challenges the status quo; fosters innovation and continuous improvement
• Applies business acumen skills to help grow the business

Qualifications:

• Requires a BS or MS in Biochemistry, Chemical Engineering, Life Sciences or other closely related discipline; PhD or equivalent preferred
• 7-10 or more years Industry experience in pharmaceutical and biological operations, including biological/protein process development.
• 8-10 years managerial experience in the pharmaceutical, biotechnology, or biological industry.
• Requires advanced business knowledge, general management, and leadership with the capability to lead multiple R&D functional teams.
• Experience in long term strategy development for global functions desired.
• Working knowledge of the Federal Food, Drug and Cosmetic Act; sections of Title 21 of the Code of Federal Regulations; FDA guidelines and current division review policies, ICH guidelines and Relevant EU guidelines.
• Substantial experience in direct interaction with FDA such as making presentations on proposed process changes and development projects is desirable.
• Experience leading R&D groups and overseeing transfer of product from early development to full manufacturing. Familiarity with biological products, cGMP, FDA and international regulations. Demonstrated senior level leadership and strategic ability. Exposure to U.S. and E.U. government requirements is desired.
• Demonstrated leadership dealing with multiple problems/issues which may arise the from commercial production operations function and/or product development work streams. Problems may be both technologically and culturally complex.