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.
Director, Molecular Profiling, Cell Therapy Development (CTD) – Leadership Role
Minimum of 10 to 15 years industrial experience in Biologics or Cell Therapy Development.
Ph.D. in relevant science field
This is a scientific leadership role in Product Science Team within Cell Therapy Development (CTD) at Celgene, with responsibility for molecular profiling of cell therapy products to enable definition of critical quality attributes (CQA). Specifically, the incumbent is responsible for developing product profiling methods for cell therapy product characterization, from candidate nomination through commercial registration - both from the internal Celgene pipeline and from third party collaborations. This individual will be a key member of the Product Science leadership team and is anticipated to take on increasing responsibilities as the cell therapy portfolio and organization expands.
Responsibilities include, but are not limited to:
- Create, define, and lead Product Molecular Profiling team within the Product Science organization to meet the expanding needs of the Celgene cell therapy pipeline.
- Lead Molecular Profiling team with responsibility of product molecular profiling and data mining to enable CQA definition and product characterization, including assay development (e.g, next-generation sequencing, microarray, transcriptome arrays, proteomics) HTP screening, data analysis/mining via bioinformatics and data management.
- Together with Attribute Science, Process and Analytical Development group, design and execute comparability study if required
- Collaborate with I/O TCoE,RIKU and Translational Development group to advance Celgene cellular immunotherapy and CTD.
- Representing Molecular Profiling group and establish effective interactions with internal and external business partners to advance and establish the value proposition of clinical candidates.
- As required, conduct due diligence and otherwise support business development initiatives to add assets to the Celgene cellular immunotherapy portfolio.
- Deliver timely data and product & 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.
- 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 Molecular Profiling staff to function effectively in cross-functional teams and collaborations.
- Maintain a balanced use of internal and external (CMO/CRO) resources to ensure maximal efficiency and prioritization of programs. Budget and track external expenses for CMO/CRO analytical activities.
- Interact effectively and transparently with functional leads within Cell Therapy Development, and with other Celgene stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Clinical and Commercial Manufacturing, Project Leadership, Business Development, Alliance Management, etc.).
- Provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel related activities across CTD.
- Ph.D. in relevant scientific discipline required
- 10 to 15 years molecular profiling and bioinformatics experience with exposure to cell therapy or biologics development
- Solid understanding of how Biopharmaceutical Development integrates with key business partners
- Proven leadership ability to align, motivate and empower team members
- The ideal candidate will also have experience in interacting with CROs
- Demonstrated ability for critical thinking, problem solving and innovation
- Effective communication, collaboration and negotiation
- Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment
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.