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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.
Director - Product Attribute Science, Cell Therapy Development (CTD)
Minimum of 10 years industrial experience in Biologics or Cell Therapy Development.
Ph.D. in relevant science field
This is a scientific leadership role in Product Science Group within Cell Therapy Development (CTD) Department at Celgene, whose mission is the definition of critical quality attribute (CQA) for cell therapy products. Specifically, the incumbent is responsible for developing analytical methods for characterization of cell therapy products, both from the internal Celgene pipelines and from third party collaborations, from candidate nomination through life cycle management, and looking for correlations with clinical outcomes in collaboration with Translational Development (TD). This individual will be a key member of the Product Science leadership team and is anticipated to interact extensively with business partners inside and outside CTD, and take on increasing responsibilities as the Cell Therapy portfolio and organization expands.
Responsibilities include, but are not limited to:
- Lead Attribute Science group with responsibility of CQA definition and product characterization, including assay development, high throughput screening, data analysis and management,
- Lead and expand Attribute Science team within the Product Science organization to meet the expanding needs of the Celgene Cell Therapy pipeline.
- Lead the overall scientific, technical and operational efforts within Product Science organization with regards to product characterization methods development, lead new assay conceptualization & selection.
- Support process monitoring and characterization, including starting material and process intermediate. Together with Process and Analytical Development, design and execute the comparability study.
- Provide SME support and provide CMC root cause analysis for clinical investigation.
- Deliver timely data and process knowledge needed to meet Celgene project milestones and associated regulatory requirements.
- Build the capabilities, and phase appropriate strategies that enable fast to market product development and commercialization. Maintain current awareness in areas of expertise.
- Collaborate extensively and effectively with business partners inside and outside CTD, particularly with I/O TCoE, TD and RIKU to advance Celgene cellular immunotherapy.
- Establish competitive intelligence around competitor product attributes to enable competitive positioning of the Celgene Cellular Immunotherapy products with respect to regulatory and commercial considerations. Raise corporate awareness of the challenges and opportunities of the Cellular Immunotherapy space.
- Maintain currency with applicable global regulations and industry standards for analytical methods and testing of cell therapy products.
- As required, conduct due diligence and otherwise support business development initiatives to add assets to the Celgene Cellular immunotherapy portfolio.
- Identify and establish partnerships with external vendors to leverage capabilities not available in-house.
- Share responsibility for the group’s scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support discovery and product development.
- Develop the attribute science staff to function effectively in cross-functional teams and collaborations and provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel related activities across CTD
Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment, and with CRO
- Ph.D. in relevant scientific discipline required
- 10 to 15 years pharmaceutical analytical experience with exposure to all stages of cell therapy or biologics development
- Direct experience in analytical development and regulatory requirements to support early and late stage product development and global commercial registration submissions
- Proven leadership ability to align, motivate and empower team members
- Strong sense of value of investment and ability to develop cost-effective development plans
- Effective communication, collaboration and negotiation
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.