Other Locations:US- NJ- Warren
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Senior Manager, Cell Therapy Development - CAR-T
Cell Therapy Development, GPDO
10 years relevant biopharmaceutical experience
PhD in a scientific discipline
Leadership position in Cell Therapy Development. Responsible for executing on global CMC development strategies and leading cross functional activities required for the technical development of cell therapy products. Working under the direction of the CMC Team Leader the short-term priorities are to execute on the delivery of the quality dossier to support a CAR T cell EU MAA and J-NDA, as well as to enable global clinical study programs in adult and pediatric patients. Provides committed and accountable leadership for assigned technical/functional deliverables. Works under the direction of the CMC Team Leader to support program specific development activities for Celgene cell therapy programs from candidate nomination throughout product life cycle. Partners closely with key stakeholders and works collaboratively across functional areas, and within external collaborations. The position is based in the US (Summit or Seattle).
Responsibilities will include, but are not limited to:
- Drive execution of the Global Project Team’s and Joint Project Team’s product-specific regulatory strategy for global CAR T cell program in EU, Asia-Pacific and ROW.
- Oversee the preparation of the quality documents to enable commercial filings across the territories, ensuring alignment of global documents with Celgene partners, and compliance with identified regulations and guidances. Write, review and approve documents as needed. Deliver documents to Regulatory CMC.
- Oversee the preparation of the quality documents to enable clinical trial submissions (CTA/IND/CTN) and amendments, as well as GMO submissions across the territories. Author and review responses to Health Authority questions, where needed liaise with relevant subject matter experts internally and externally.
- Interface effectively with Regulatory CMC to enable the review, approval and submission of regulatory documents
- Interact with CMOs, collaboration partners, consultants, and national Celgene affiliates to ensure alignment around regulatory requirements and resulting operational design and regulatory submissions.
- Contribute to Health Authority briefing books and slide decks, may represent function in HA meetings
- Guide, manage and participate in technical, CMC, operational and related aspects of the Celgene CAR T cell program in the EU, Asia-Pacific and ROW to identify or anticipate, manage and minimize regulatory risks.
- Represent cell therapy development on joint alliance workstream meetings.
- Elevate relevant discussions with the functional area management and global project team.
- Communicate effectively with Cell Therapy Development functions and with other Celgene stakeholders (Quality, Clinical, Regulatory, Translational, and Commercial Manufacturing and Supply Chain).
- Influence Celgene’s global CMC strategy for CAR T cell technologies.
- PhD degree in Biological Science, Engineering, Pharmaceutics or other relevant scientific discipline
- 10 years biopharmaceutical industry experience with a strong scientific focus, including experience in development of advanced therapy biologics/cell therapies
- Comprehensive understanding of product design and how development integrates and partners with key functional areas such as Quality, Clinical, Regulatory, Manufacturing and others.
- Proven ability to work effectively with cross-functional stakeholders (internal and external collaboration) in a complex/changing global environment
- Effective communication, collaboration and negotiation
- Proven ability to deliver on complex development plans
- Ability to understand and communicate risks, as well as developing and executing contingency plans
- Global mindset and willingness to travel
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.