O&EM Process Owner for Cell and Gene Therapy
Roche
Basel, Switzerland
vor 1 Tg.

O&EM Process Owner for Cell and Gene Therapy

This job is available in 2 locations Category Supply Chain Job Id 202202-107682 Save job Save job JOB DESCRIPTION

O&EM Process Owner for Cell and Gene Therapy

Location : South San Francisco, Basel

Orchestration and Exception Management (O&EM) is a new and fundamental capability for Pharma Technical Operations (PT) in order to deliver a future portfolio of Cell & Gene Therapy (CGT) products.

This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges : living products (e.

g. cells) need to be delivered to patients in highly individualized supply chain models, which meet fast turn-around-times at a zero-error quality level.

Orchestration and Exceptions Management is one of three end-to-end value chain (E2E VC) groups, responsible for the virtual treatment journey (data, transactions and documents).

It is complementary to supply chain management, which focuses on the physical journey (materials, specimens, products), and patient operations, which is responsible for the patient journey .

As the O&EM Process Owner for Cell and Gene Therapy, you will be shaping the future of CGT at Roche. You will be responsible for the central digital backbone and orchestration engine of the value chain and for ensuring that the business processes for make-to-order CGTs (e.

g. autologous cell therapies, individualized mRNA / DNA therapies) and make-to-stock gene therapies (e.g. weight based dosing gene therapies) are enabled.

You will contribute to the evolution and growth of the capability from supporting the first early-stage clinical trials to being able to support a full portfolio of diverse CGT modalities in clinical and commercial stages.

You will bring your passion and many skills to the table including operating in a fast changing environment, the ability to approach complex topics with structure and direction, and the ability to execute strategic vision.

Key Responsibilities & Job Requirements

The O&EM Process Owner for Cell and Gene Therapywill

Business Process Ownership

Design and maintain an up-to-date picture of the business processes of CGTs on a granular transactional level

Collaborate with the E2E VC business process owner to ensure that the transactional business processes map to the overall E2E VC business models / processes

Collaborate with technical experts to ensure that transactional gaps, challenges and change requests are well understood and addressed to ensure transactional enablement

Treatment Management Platform Co-innovation & Implementation

On the project as TMP Product Owner, be globally responsible from the business function for the design, configuration, and deployment of the Roche Treatment Management Platform (TMP), a software co-innovation with SAP SE, to enable the CGT business processes.

As TMP Product Owner, collaborate with Roche IT and supplier IT resources on the SAFe TMP design and deployment project team.

Translate the O&EM strategic vision & roadmap into product-specific requirements, priorities, and design for the TMP.

Professional (not disciplinary) leadership of the TMP project team that consists of business and IT experts. The team’s responsibility is to design the solution, collaborate with IT, enable configuration and deployment, and conduct change management activities.

As a key member of the O&EM Product Owner team, collaborate with other business product owners that own integrated products or sub-products (e.

g. CoC / CoI, Labeling).

Strategic Capability Development

Own the TMP product roadmap to ensure business requirements and timelines are supported and ensure fit to the overall platform strategy and roadmap.

Collaborate with SAP and consortium partners on co-innovating the SAP TMP product, grow the consortium, and share our vision

Together with IT, regularly assess the market to identify potential partners that could de-risk, accelerate or reduce the cost of our TMP investments.

Operational Excellence

Work closely with the operational resources that use the TMP to ensure that user needs are met, the system and solution is enabling CGT operations 24 / 7, and to ensure business continuity.

Additionally, the collaboration has the goal to mature the operational model, identify and implement continuous improvement topics, achieve shorter lead times with higher degrees of automation, and enable operational roll out of change requests (technical changes, portfolio changes, deployments)

Ensure that the right business support model is in place and support the process in case of escalations.

Stakeholder Management

Manage internal and external stakeholder relationships relevant for the TMP

With the TMP product owner team, support stakeholder and change management activities such as communication, training, and testing.

Who You Are

Qualifications, Experience & Education

Bachelor’s Degree, Master’s Degree, or equivalent academic qualification in Engineering, Life Sciences, or Supply Chain / Value Chain Management

Prior experience (7+ years) in Supply Chain or Operations with strong technology acumen in the biotechnology and / or pharmaceutical industries, with cell and gene therapy experience preferred

Experience related to virtual treatment journey management for CGTs in complex and large organizations

Prior experience in product management and a deep understanding of complex business system design, development, testing, deployment, and life-cycle management

Familiarity with supply chain enabling technologies (e.g. SAP ECC, SAP S4 / HANA, Web Enabled Solutions, Bar Coding, Labelling, etc.)

Prior experience in working with agile teams (e.g. SAFe, SCRUM, Design Thinking)

Good understanding of regulatory requirements related to digital products and services in pharma (e.g. GDPR, HIPAA, GxP, Annex 11, 21 CFR Part 11, specific regulations for ATMPs)

Critical Competencies

Ability to navigate new innovation topics in large and complex organizations

Ability to define compelling strategies for business capabilities (such as O&EM digital products and services for CGT)

Ability to make strategic and tactical decisions based on limited and uncertain information in a complex and ever changing environment

Strong influencing and negotiation skills, including a track record of influencing without authority and driving cross-functional activities to successful conclusion

Outstanding collaboration skills

Excellent verbal / written communication and presentation skills, including the ability to distill complex content into clear, concise, and engaging communications and manage relationships with all levels / functions within and outside the organization

Proven track record of translating complex problems into innovative solutions through a patient-centric and customer-centric lens and transforming organizational mindset and capability to capture value

Ability to challenge the status quo, target break-through innovations, and benchmark internally and externally to bring best practices to Roche

Position requires international travel : up to 10%

If you have questions then please check our FAQs and videos on careers.roche.ch / faq

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups.

Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel / Kaiseraugst site, which is one of Roche s largest sites. .

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave.

Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

Job Level :

Individual contributor

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