Leader/ Expert Analytical Sciences

Job content

Job Summary: Reporting to the Head of Global Quality Control this position is responsible, in collaboration with cross functional stakeholders, for the commercial QC strategy for ATMP products and implementing the strategy into respective QC network locations. The scope of programs includes viral vector based Gene Therapy, gene edited Cell Therapy, neo-antigen based mRNA therapy and other modalities that are classified as ATMPS. The QC elements include collaboration (with a strong focus on facilitating technical implementation) with development teams on control considerations for ATMP programs, defining the commercial control system, evaluation of stability program requirements, establishment of risk-based assessment of product quality attributes, evaluation of appropriateness of the specification, consultation on rapid microbial methods that support the safety of small volume to single patient batches, and the evaluation of appropriateness, and recommendation for management of retain samples and reference material. The strategy should consider where and if “phase appropriate” Quality Control standards are applicable, and should take into consideration the ability to industrialize the proposed control system. Applicability for PAT and rapid release concepts should also be evaluated. With consideration for all critical safety/efficacy/control concepts and approaches of the ATMP pipeline, establish strong collaboration with Development so that aligned approaches and analytical readiness can be ensured by supporting the operational units (based on standard practices and platforms incl. appropriate commercial ATMP compliance). Develop the concept and roadmap towards implementation of a control system, providing a risk-based evolution of the controls considering characterization approaches with later on release spec needs. Evaluate and clarify the similarities across the modalities considered ATMPs and establish a strategic framework that enables rapid development through “platform” approaches to these. Where the needs of the modalities are different (eg. Individualized therapies vs. off-the-shelf ATMPs) develop and justify alternative standard approaches that allow for fit-for-purpose management of the testing and control of these. Take accountability and ownership for the commercialization readiness phase, and robust supply of different novel modalities from respective QC network locations. These strategies and platform approaches should leverage synergies of the existing QC network, platforms and business where possible, but where innovation is needed, work with members of the relevant functions to design fit-for-purpose methodology to manage risk and deliver products to patients. Collaborate with stakeholders to create an agile and adaptive data platform for collection, cross-functional review and evaluation of data to drive improvement and innovation into the technical and clinical development footprint. Keep abreast of technology advances in both data informatics and analytical testing to be an early adopter of the technology advancement that helps accelerate product development or provides better understanding of product function in vivo. Job Responsibilities involve but are not limited to the following:

• Develop the Global Quality Control concepts and approaches for the control and lifecycle of ATMP products
• Create a future ATMP specific QC lab operation vision including new technologies and automation (including IT and data analytics capabilities)
• In collaboration with Analytical Development finalize the approaches for the various ATMP products based on Development approaches for Control Strategy (CQAs and non-CQAs), comparability and stability.
• Advise and implement a process for justification of differences in approach across the pipeline, based on risk and knowledge of the Regulatory Framework by which these products will be evaluated (and the lifecycle state of the product).
• Contribute to position papers that address the Quality Control of ATMPs and that help to influence the external environment
• Evaluate the technology landscape and bring to the attention of the program teams new technology that enables faster development or better analytical capability of ATMPs
• Define the methodology for the evaluation of stability requirements for the ATMP products
• Define the methodology for the evaluation of and the justification for the Retain Samples and Reference Material programs for the various ATMP product types. Leadership
• Network leadership
• As a leader within the QC network drives strategic discussions, network activities and decisions. Ability to influence within a matrix structure, facilitates groups across cultures, countries, technical competencies and organizational levels. Operate effectively even in ambiguity.
• Ability to set the direction from the strategy into the execution by bringing the direct experience from other comparable projects (industry experience). (lived through, proven & developed)
• Ownership and Accountability
• Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations. Makes quality decisions and resolves problems rapidly.
• Customer Focus
• Strong focus on customer support and creation of value. Manages stakeholder expectations effectively.
• Decision Making – Demonstrates sound judgment in synthesizing data and information to make timely decisions; communicates, influences and escalates issues and decisions as needed.
• Planning/organization – ability to establish programs/plans, achieve support by stakeholders, drive execution and deliver results in a changing environment
• Teamwork & Communication
• Creates an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation, and inspires teams to achieve goals in the immediate and longer term.
• Mindset- Embodies PT lean principles and methods while fostering a mindset of quality, innovation and continuous improvement throughout the organization by encouraging experimentation and learning. Is an active and visible change agent, promoting flexible and open mindset to new opportunities.
• People Management- As the program advances, the Leader/Expert could build/manage a team of direct reports. Qualifications
• BA/BS or advanced degree (MA/PhD) in a technical or scientific discipline with 10 years relevant experience in the ATMP and/or biopharmaceutical industry
• Direct experience leading a Quality Control, or closely related Analytical Development, Quality Management, Manufacturing function for a Cell or Gene Therapy organization, experience in the ATMP QC commercial space.
• Strong scientific and technical understanding of Cell and/or Gene Therapy development
• Strong knowledge of the Regulatory requirements and the evolving standards applicable to ATMPs
• A proven track record with authoring CMC sections and global health authority interactions (e.g. inspections, F2F meetings, scientific meetings, Q&A interactions etc.)
• International experience / working in global business environment
• Self-driven, detail oriented and able to orchestrate multiple activities at once
• Communicate effectively in difficult situations and at all levels of the organization
• Strong Collaborator
• History of effective interaction/engagement with Health Authorities (review bodies and inspectorate) on Quality Control Topics
• Present excellently in writing and orally
• Able to mobilize the organization by building a trustful and effective relationship with the involved colleagues
• Fluency in English (speaking, writing, reading) *Flexible work arrangements and remote work from a US-based location outside of commuting distance from a Genentech location, will be considered #PTcareers