Global Head of Technology Transfer/Validation

Location:, Kankakee County
Job Type:Full Time

About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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 incumbent will have a broad global impact across Operations and Engineering, developing and executing technology transfer and qualification strategies for new and already licensed products as they are transferred within the CSL network and externally. The role is responsible for ensuring that Tech Transfer, Qualification & Validation activities across the company are guided, supported and executed according to project plans. The Executive Director, Global Tech Transfer and Qualification is responsible for ensuring that Recombinant Product Development (RPD) and Plasma Product Development (PPD) have innovative and efficient systems, processes, tools and practices that are available and effective in supporting technology transfer activities both internally and externally to CSL Behring. In addition, working closely with PD SVPs and Directors, the incumbent will co-ordinate establishment and communication of PD project plans and strategy.

Main Responsibilities and Accountabilities:

1. Tech Transfer

  • Leads and directs the staff responsible for the planning, development and coordination the transfer of CSL-developed processes and analytics for the production of therapeutic recombinant and/or plasma derived proteins from RPD and PPD functions to CSL Product Development facilities, CSL Behring manufacturing sites and to external Contract Manufacturing Organisations (CMOs).
  • Leads and directs the staff responsible for the planning, development and coordination for the production of therapeutic recombinant or plasma derived proteins from either CSL Behring or other external organisations to RPD or PPD
  • Support the strategic expansion of CSL Behring’s operations facilities by leading, planning, developing and coordinating the transfer of Commercial products from one CSL Behring site to another
  • Influence and negotiate with Engineering and Operations leads within the Project Canberra structure to define Tech Transfer plans within major capital expansion projects
  • Leads and directs the staff responsible for the development of new and innovative procedures for ensuring the success of Tech Transfer activities
  • Leads and directs the staff responsible for the management and/or support of key outsourced activities such as cell banking, analytical testing or characterisation studies as appropriate e.g. co-ordinate documentation with relevant functions, business development, contracts & sourcing or QA
  • Provides oversight and co-ordination for the generation of documents describing process development policy or procedures, interfacing where necessary with PD Directors, QA and Regulatory Affairs.
  • Collaborating with department heads and global project managers to develop detailed process development specific project plans
  • Planning and maintenance of a process development master schedule of technology transfer project activities for process development and manufacturing
  • Leads and directs the staff that provides support and oversight to the CMC Lead/Technical Lead and others as necessary to identify and facilitate resolution of issues relating to process and product quality
  • Capture and respond to cross project learning
  • Establish project plans and communication lines with internal and external parties to ensure that milestones are on track and potential issues are rapidly assessed and resolved before they become critical.
  • Preparing and presenting progress reports to senior management, scientific committees and regulatory bodies.
  • Providing leadership and direction for implementing cultural change and the alignment of global sites

2. Qualification & Validation

  • Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry practices for cell therapy.
  • Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to cell therapy production.
  • Lead, develop and implement the master validation plans for process, equipment and facilities, in collaboration with the validation and technical SME network.
  • Develop and guide process validation, qualification and process monitoring strategies and framework.
  • Guide the teams to storyboard and present CSL’s global validation framework, standards and approaches during major health authority inspections.
  • Shape and review the technical content in the validation sections of the dossier
  • Support Quality and BT for validation of systems, as needed
  • Provide validation expertise for issue resolutions to support deviations or CAPAs. and audit findings
  • Develop/approve cGMP documents including, but not limited to, Master Validation Plans, protocols, etc.
  • Collaborate with QA to monitor and respond to audit observations related to appropriate regulations
  • Track department performance metrics and provide progress reports to stakeholders
  • Lead global validation team providing oversight of internal programs and with direct responsibility for validation activities at contract manufacturing organizations, including validation gaps assessments during CMO selection and tech transfers
  • Provide oversight via review and approval of network site level deliverables, including Validation Master Plans, process validation protocols and risk assessments.
  • Design qualification strategies to support novel applications with CSL’s manufacturing network and technologies
  • Facilitate harmonization amongst sites and adoption of industry best practices
  • Collaboration with Quality Assurance to maintain high standard of compliance in all program deliverables.

3. Leadership of People and Teams

  • Directly oversee Tech Transfer and Qualification staff. Responsible for development of the department, including motivating in a manner that promotes the achievement of CSL’s business goals and objectives.
  • Establish performance goals and strategic/operational objectives for direct reports
  • Appraise performance of department personnel, coach and counsel employees..
  • Builds, develops and manages leadership team capable of engaging employees’ commitment to achieve the company’s goals and objectives, while complying with company policies.
  • Ensure competency & capabilities to provide sustainable production reliability;
  • Promotes high employee engagement and a positive work environment.
  • Responsible for organizational design and staffing decisions. Recruit, retain, train and develop the team.
  • Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • Resolve employee related problems with the collaboration of Human Resources.

Education

  • Bachelor or Master degree in an Biological Science or Engineering discipline or local equivalent; MBA preferred

Experience

  • At least 15 years experience in related process development activities.
  • 5+ years experience of project management/Technology Transfer
  • 5+ years experience in validation and qualification
  • Understanding of and experience in the production of bio-therapeutic proteins, including cell culture, chromatographic separation of proteins and other methods of protein purification, formulation activities, bio-analytical in-process and release assays, from bench-scale to multiple-1000L scale.
  • Strong understanding of the regulations (FDA, EMEA, TGA) associated with cGMP production of proteins for clinical trials, process validation & characterisation required for BLA applications.
  • Project Management experience across multiple functions with multiple levels of stakeholders
  • Providing leadership and direction for implementing cultural change and the alignment of global sites
  • Demonstrated leadership skills with ability to motivate, guide, train, coach and develop subordinates.
  • Excellent verbal and written communication. Must be able to read, write, and speak English.
  • Must have strong technical writing skills;
  • Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
  • Strong organizational, analytical and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.

Competencies

  • Managerial Courage: Does not hold back anything that needs to be said; provides current, direct, complete, and ‘actionable’ positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation quickly and directly; is not afraid to take negative action when necessary.
  • Business Acumen: Knows how businesses work; knowledgeable in current and possible future policies, practice, trends and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
  • Drive for Results/Execution: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
  • Strategic Agility: Sees ahead clearly; can anticipate future consequences and trends accurately; has broad knowledge and perspective; is future oriented; can articulately paint credible pictures and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans.
  • Decision Quality: Makes good decision based upon a mixture analysis, wisdom experience, and judgment; most his /her solution and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
  • Innovation Management: Is good at bringing the creative ideas of others to market; has good judgment about which creative ideas and suggestions will work; has a sense about managing the creative process of others; can facilitate effective brainstorming; can project how potential ideas may play out in the marketplace.
  • Developing Talent: Provides challenging and stretching tasks and assignments; holds frequent development discussions; is aware of each person’s career goals; constructs compelling development plans and executes them; pushes people to accept developmental moves; will take on those who need help and further development; cooperates with the developmental system in the organization; is a people builder.
  • Interpersonal Savvy: Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.
  • Managing Vision and Purpose: Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision sharable by everyone; can inspire and motivate entire units or organizations.
  • Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvement in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
  • Organizing: Can marshal resources (people, funding, material, support) to get things done; can orchestrate multiple activities at once to accomplish a goal; uses resources effectively and efficiently.
  • Priority Setting: Spends his/her time and the time of others on what’s important; quickly zeros in on the critical few and puts the trivial aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks; creates focus.

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act.