Celgene Executive Director, Biologics Drug Product Development in Summit, New Jersey
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 senior leadership position in Biologics Development & Manufacturing to lead all large molecule Drug Product Development resources and activities at Celgene, from early development through life cycle management. This role provides committed and accountable leadership for phase-appropriate product formulations, presentations and processes to meet development and commercial needs. As a member of the Biologics Development Leadership Team, this position will also participate in governance and other leadership activities, interact with business partners across Celgene, and may be involved in 3rd party collaborations.
Responsibilities will include, but are not limited to:
1.Oversee all scientific, strategic, planning and execution aspects of biologic formulation development, drug product process development (including scale-up), primary packaging development, technology transfer support, and drug product characterization activities
2.Build and lead the Biologics Drug Product Development organization to meet the expanding needs of the Celgene biologics pipeline and commercial portfolio
3.Strengthen internal capabilities for large molecule formulation and product development and hire a best-in-class team to design and execute phase-appropriate activities from early development through lifecycle management
4.Interface effectively with Research & Early Development to offer guidance during lead optimization and conduct formal Developability Assessments to enable Candidate Nomination
5.Develop platform methods and phase 1 formulations to enable fast to FIH strategies
6.Develop commercial formulations and drug product presentations to meet TPP and LCM requirements
7.Develop and support the transfer of robust DP processes to manufacturing sites; provide in-plant support.
8.Maintain currency with applicable global regulations and industry standards
9.Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies
10.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.
11.Collaborate effectively with other Biologics Development groups, Quality Operations, Supply Chain and other business partners to establish high performing teams and ensure successful outcomes.
12.Provide membership, support and leadership as needed to cross-functional Biologics Development teams and collaboration joint CMC teams, and represent Celgene on collaboration committees, as appointed.
13.Lead a team of scientists and engineers, ensuring their individual and organizational development.
14.Manage resources, budgets, contracts and external relationships necessary to the effective functioning of the group
15.Participate in and lead due diligence assessments of new business development opportunities, as required
20 years experience in Biologics Drug Product Development.
Ph.D. in relevant science or engineering field
Skills/Knowledge Required :
Ph.D. in relevant scientific or engineering discipline
20 years pharmaceutical biologics drug product development experience
Experience in early stage and late stage development programs, and launch/commercial stage products
Understanding and experience of the integration of Pharmaceutical Development activities to Quality, Regulatory CMC, Manufacturing, Supply chain, Non-Clinical, Clinical, and other functional areas
Experience in the development of products using delivery devices is an advantage
Experience in the preparation and approval of regulatory documents and in regulatory interactions
Proven ability to lead cross-functional and technical teams and align, motivate and empower team members
Proven leadership capabilities in a prior role
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
Ability to prepare and execute complex resource, budget and strategic 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.
Executive Director, Biologics Drug Product Development
Location: Summit, NJ, US
Job ID: 17000167