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.
This is a new, senior leadership position in Biologics Development to oversee clinical manufacturing of large molecule drug substances and drug products. This role provides committed and accountable leadership for delivery of clinical inventory to meet Global Project Team and Biologics Development needs, and is responsible for the CMO relationships, plans and strategies to ensure short and long term security of supply. The incumbent will also lead development of a commercial manufacturing strategy for Biologics at Celgene and participate in its implementation within Global Pharmaceutical Development and Operations. As a senior leader within Biologics Development, this position will also participate in governance and other leadership activities, interact with business partners across Celgene, and may be involved in 3 rd party collaborations and governance committees. Responsibilities will include, but are not limited to: Ensure availability of bulk drug substances and clinical drug products to enable IMSC to meet all Global Project Team needs for clinical studies, and to support all other development activities. Identify and qualify CMO’s to deliver the required quantities of DS and DP, executing supply agreements, overseeing technology transfer, and managing the execution of those agreements to meet these objectives. Support a growing, diverse pipeline of biologics, addressing increased manufacturing complexity and cost. Participate in initiatives to establish in-house clinical GMP production capabilities for drug substances and products. Evaluate and establish strategic relationships with CMO’s to gain preferred customer status and security of supply for development and initial commercial quantities. Lead the development of a commercial manufacturing strategy for biologics at Celgene, including CMO and in-house production, adapting the strategy to evolving pipeline and commercial priorities. Lead a team of engineers engaged in these activities, ensuring their individual and organizational development. Collaborate seamlessly with other Biologics Development groups, Quality Operations, IMSC and other business partners to establish high performing teams and ensure successful outcomes. Prepare and manage the biologics supply budget, providing short/long term forecasts and regular updates as required. Ensure project and investment decisions are anticipated and timely, and strategies are developed to balance financial, project and regulatory risk. Provide membership, support and leadership as needed to cross-functional Biologics Development teams and collaboration joint CMC teams, and represent Celgene on JMC and other collaboration committees, as appointed. Contribute to, review and approve regulatory CMC submissions to ensure their quality and technical content. Participate in and lead due diligence assessments of new business development opportunities. Serve as a member of the Biologics Development leadership team, participating in portfolio review and project governance meetings and providing guidance for best practices and direction for continuous improvement. Report to the Senior VP Biologics Development, with accountability to Biologics Development, to Global Pharmaceutical Development and Operations, and indirectly to the Franchise Development Committees. Qualifications
Minimum of 20 years industrial experience in Biologics Development / Manufacturing. Ph.D. in relevant science or engineering field
Skills/Knowledge Required: Ph.D. in relevant scientific or engineering discipline required.20 years pharmaceutical biologics development and/or manufacturing experience.Experience of working with or in contract biologics manufacturing.Experience in both drug substance and drug product development and supply.Experience in early, late stage development programs and launch/commercial stage products.Solid understanding and first-hand experience of the integration of Pharmaceutical Development activities to Quality, Regulatory CMC, Tech Ops, Non-Clinical, Clinical, and other functional areas.Proven ability to lead cross-functional and technical teams and align, motivate and empower team members. Able to engage and align other stakeholders outside the project team.Demonstrated ability for critical thinking and innovation.Ability to understand and communicate risks and develop and execute contingency plans.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.