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 novel therapies in Hematology, Oncology, Inflammation and Immunology that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. We are building in-house biologics development capabilities over the next few years to support our growing portfolio of exciting biologic candidates. This is a unique opportunity to join the biologics development team and help us build a first class, science and technology based organization. We are looking for talented and experienced scientists and engineers that are excited by the opportunities provided by a fast growing organization, are interested in advancing our science and to contribute to our dynamic culture.
The Director will build and lead the late stage Biologics Formulation and Drug Product Development organization and define and deliver product development strategies and outcomes for Celgene's therapeutic protein candidates from the internal pipeline and from third party collaborations.This individual will be a key member of the Late Stage Biologics Development leadership team and is anticipated to take on increasing responsibilities as the Biologics portfolio and organization expands.
• Build and lead the Biologics Formulation and Drug Product development organization to meet the expanding needs of the Celgene biologics pipeline.
• Establish internal capabilities for biologic formulation and drug product development and hire a best-in-class team to design and execute phase-appropriate development activities for biologics products in mid to late stage development and up to commercial registration.
• Responsible for all scientific, strategic, and project planning and execution aspects of biologic formulation development, drug product process development, primary packaging development, technology transfer, scale-up, and validation activities, based on organizational goals and project timelines.
• Responsible for establishing and maintaining high scientific and technical standards within the group and for all development activities.
• Will maintain currency with applicable global regulations and industry standards for formulation and drug product development for recombinant therapeutic proteins.
• Will participate in drug product regulatory strategy development, write and review regulatory filings, and participate in meetings with global regulatory agencies.
• Will oversee interactions with contract manufacturing organizations to deliver drug product supplies for clinical development up to commercial registration.
• Will work cross functionally, leading or participating in matrix teams to develop and execute project plans to meet established goals and timelines.
• Will interact effectively and transparently with functional heads within Biologics Development, and with other Celgene stakeholders (Quality, Regulatory CMC, Global Manufacturing, Project Leadership, Business Development, Alliance Management, Commercial, and Clinical organizations).Will serve as a key strategic member of the Late Stage Biologics Development leadership team, assessing capabilities and processes and providing guidance for best practices and direction for continuous improvement.
Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or relevant scientific discipline with a minimum of 15 yrs industrial experience in formulation, drug product development, and registration of therapeutic protein products.
• Demonstrated track record of successful formulation and drug product development, supporting clinical/commercial programs for recombinant protein products, including filing of INDs/IMPDs and BLAs.
• Deep technical understanding of all aspects pertaining formulation and drug product development of liquid and lyophilized biological products, including experience with multiple primary packaging configurations and combination products.
• Thorough knowledge of current US, EU , and global Regulations, ICH guidance and relevant standards and quality system requirements for biological product manufacturing.
• The ideal candidate will also have proven experience with contract manufacturing organizations including establishing and managing clinical supply agreements.
• Proven leadership ability to align, motivate and empower team members.
• Demonstrated ability for critical thinking, problem solving and innovation.
• Strong sense of value of investment and ability to develop cost-effective development plans.
• Effective communication, collaboration, and negotiation skills.
• Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment.Potential to take on increasing responsibilities as the Biologics portfolio and organization expands.
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.