Other Locations:US- NJ- Summit West
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.
Associate Director, Biologics CMC Program Leader
Biologics Development and Manufacturing
Minimum of 10 years of industrial experience in Biologics Development.
Ph.D. in relevant science or engineering field
The Associate Director level position will lead Biologics CMC (BioCMC) program team(s) and is accountable for strategy and delivery of all CMC aspects of process and product development of assigned molecules for early stage development programs. This is a matrix leadership role that will collaborate cross-functionally to develop CMC program strategies and will coordinate functional activities to deliver on the program plans. This is a highly visible and influential role in the organization and will interact extensively with business partners and senior leadership across Celgene and external collaborators.
Responsibilities include, but are not limited to:
- Lead matrix teams of functional line members and use risk-based and QbD approaches to develop and deliver early stage development strategies for biologics products within Celgene’s portfolio.
- Define CMC goals, milestones and timelines for the team, coordinate and monitor progress, and manage team activities to ensure successful implementation of the endorsed development strategy.
- Represent the BioCMC team(s) in CMC technical and program reviews with governance boards and senior management.
- Serve as the primary liaison with Global Project Teams and Technical Commercialization Teams.
- Provide regular communications to the team, sub-teams, functional lines, stakeholders, and management. Escalate issues and risks according to governance procedures.
- Contribute to the development and implementation of the BioCMC stage gates, milestones, and processes for early stage development programs.
- Provide guidance on best practices and direction to early-stage BioCMC teams to support harmonization, efficiency, and continuous improvement.
- Maintain currency with applicable global regulations and industry standards for development of biological products.
- Create a high functioning team, holding team members accountable for performance, and mentoring/coaching as needed. Provide input into the performance reviews of team member.
- Participate in regulatory strategy development, regulatory filings, and meetings with regulatory agencies, as appropriate.
- Ph.D. in relevant scientific or engineering discipline and 10 years preferred or MA/BS degree and 15+ years preferred/considered.
- 10 years of experience in biotech/pharmaceutical industry with exposure to all stages of biologics development w Ph.D. preferred.
- Proven record of successful technical leadership of CMC development teams.
- Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a cross functional team environment.
- Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment.
- Clear understanding of the process and functional interdependencies required to deliver a biological product to the clinic.
- Subject matter expertise in one or more functional areas (cell culture, purification, drug product, analytical).
- Strong problem solving and risk based decision making skills and a strong ability to influence or manage without direct authority.
- Highly developed interpersonal, communication and negotiation skills.
- Demonstrated ability for critical thinking and innovation.
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.