Job Description

The Position

This position is a part of the Roche Pharma Global Technical Operations (PT) team. In this role you will deliver a fast evolving portfolio of new Cell & Gene Therapy (CGT) products to bring new curative treatments to patients. 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 personalized supply chain models, which meet fast turn-around-times at a zero-error quality level. Efforts are ongoing to build CGT capabilities that serve as enablers to success with new molecular modalities (reprogrammed cells, neo-epitope targeted therapies, viral vector based gene therapy etc.). These new CGT capabilities are designed within the context of new, patient centric value chains that facilitate a seamless transition of products, a safe exchange of personalized health data and enables a successful patient journey.

As a CGT Patient Operations Manager you will be responsible to support the evolving clinical (and eventually commercial) CGT portfolio during day-to-day operations, and to manage communication and engagement with stakeholders across the organization to ensure seamless integration of Patient Operations with other relevant functions within the Cell & Gene Therapy space, as well as across the Pharma Organization and our external customers. You will bring your many skills to the table including collaborative stakeholder management, creative problem solving and project management delivery.

The Opportunity

• You provide the day-to-day operational management of Patient Operations activities as part of the E2E Value Chain team. This includes serving as primary contact for internal clinical teams and CROs as well as treatment centers or laboratories as related to all operations required to support patients/clinical sites as part of manufacturing.
• You partner with internal/external stakeholders in providing treatment centers or collection centers the biological starting material (e.g. cells and tissues) collection and processing instructions, packaging/kit contents, and logistics needed for CGT manufacturing.
• You deliver presentations and in-depth training to CROs, treatment/collection centers, laboratories on requirements for biosample collection and/or handling procedures for cell and gene therapy products.
• You work with other Patient Operations team members and internal stakeholders in their responsibilities to execute clinical trial activities in support of the CGT portfolio.
• You provide guidance in accordance with GxP-related regulations and activities and act as responsible owner of quality events (deviations) related to Chain-of-Identity or biosample management on a patient level.
• You provide real-time customer/Treatment/Collection Center for patient level support, which may require working outside of normal business hours.
• You work with the Product Owner of Digital Customer Services to ensure proposed digital solutions align with business objectives and business processes as SME. This includes business requirements, review and validate solutions' demo, and provide feedback as business process owner/ SME.
• You assist in gathering external user feedback during the roll-out phase and addressing any operational concerns or feedback.
• You ensure and maintain the documentation of business processes, and workflows are in line with system features and improvement as well as standard business documentation procedures.

Who You Are

• You hold a Bachelors or advanced degree in scientific or healthcare-related field.
• You have 3+ years working experience in pharma, clinical settings, CRO, specialty pharmacy, patient care or related field with a focus on supply chain, logistics, and especially biosample/clinical operations.
• Direct experience in cell and/or gene therapies is desirable.
• Experience with Clinical Trial Settings is desirable.
• You have experiences with collection and testing of clinical biosamples (e.g. tumor tissue collection, apheresis/phlebotomy, cell therapy lab) in the pharmaceutical/biotech or healthcare industry (e.g. Cell Therapy Lab) including in-depth knowledge of GxP regulations in the CGT field.

Knowledge/Skill/Competencies

• Creative problem solving skills fueled by a high level of curiosity.
• Highly collaborative and able to influence, understand and align with stakeholders at all levels across the organization.
• Excellent communication skills with the ability to engage stakeholders with diverse backgrounds.
• Knowledge of applicable GxP guidelines and regulations.
• Excellent Project Management skills to facilitate meetings and track deliverables.

International travel: up to 10%

Locations

You are local to San Francisco. This is an on-site opportunity.

*Relocation benefits are available.

The expected salary range for this position based on the primary location of San Francisco is $109,100 and $202,670. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

For more information about equal employment opportunity, visit our Genentech Careers Homepage.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

Job Tags

Similar Jobs