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 position is responsible for delivering Pharmaceutical Development strategies and leading cross functional activities required for the development of pharmaceutical products as well as their associated manufacturing processes and controls. This position will provide committed and accountable leadership for development teams responsible for the pharmaceutical development of assigned compounds. This Director level position will work under the direction of Pharmaceutical Development Compound Leaders to support compound specific CMC development activities for Celgene drug candidates from candidate nomination continuing through development up to first commercial manufacturing scale, partner closely with key stakeholders, and work collaboratively across multiple functional areas.
Responsibilities will include, but are not limited to:
- Implements comprehensive, compound-specific development strategies and tactics to meet global project needs that incorporates all elements across the drug substance, drug product, analytical, quality and regulatory work space
- Leads a high-performing scientific and technical cross functional team of Pharmaceutical Development scientists and engineers
- Tracks and reports compound specific expense plans against predefined spending targets
- Ensures appropriate technical, scale-up, and production strategies and timelines are in place to meet clinical supply and registration needs, and ensures production, technology transfer, validation and regulatory outcomes, meet or exceeds industry standards
- Represent Pharmaceutical Development on the Global Project Teams for assigned compounds
- Ensures an effective Target Product Profile is in place which adequately defines the product characteristics and performance expectations to inform pharmaceutical development work
- Responsible for ensuring adequate transition plans to transfer knowledge to clinical and commercial manufacturing
- Maximizes alignment, cooperation, input, decision making, commitment and synergy, of Pharmaceutical Development team members to ensure their technical contributions, meet and exceed program objectives
- Promotes a “One-Team Culture” among scientists and engineers in drug substance, drug product and analytical development, and ensures the Compound Team operates within the mission and values of Pharmaceutical Development and Celgene
- Provides sound scientific and technical leadership and advocacy to support the development of robust manufacturing processes and products, integrating current regulatory and industry standards
- Communicates effectively and transparently with functional representatives within Pharmaceutical Development, and other stakeholders such as Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory, Clinical and Commercial Manufacturing, etc.) across the company
Minimum of 12 years experience in pharmaceutical development with Ph.D. in Chemistry, Chemical Engineering, Pharmaceutics or related disciplines. Masters degree with 15+ years of experience may be considered
Ability to engage and align key stakeholders outside of Pharmaceutical Development and the project team
- Advanced degree in relevant scientific discipline required, Ph.D. is preferred.
- 12 years pharmaceutical development experience with exposure to all stages and aspects of product development
- Comprehensive understanding of Drug Product Design and how pharmaceutical development integrates and partners with key functional areas such as Quality, Regulatory, Manufacturing, Clinical, and others
- Proven leadership ability to align, motivate and empower team members
- Demonstrated ability for critical thinking and innovation
- Highly effective at communication, collaboration and negotiation
- Accountable for delivery on complex development plans
- Ability to understand and communicate risks as well as developing and executing contingency plans for development programs
- Ability to manage ambiguity, and make sound scientific and business decisions with limited information (when necessary)
- Proven ability to work effectively with cross-functional stakeholders in a complex, changing, 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.