Associate Director, Technology Transfer CAR-T Warren United States,
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.
Responsibilities will include, but are not limited to, the following:
- Direct activities of the CTDO tech transfer function, consisting of bioengineers and analytical scientists. Ensure the development and training of staff.
- Lead technical transfers in support of the GMP implementation, scale-out, and start-up of ex-vivo cell expansion processes, while collaborating with operational owners and developmental subject matter experts.
- Interpret guidance documents for processes and analytical transfers and FDA, EMA and GMP requirements to design, develop, and implement protocols related to technical transfers of cellular products.
- Conduct risk assessments for transfer activities and establish specific transfer criteria to demonstrate successful technical transfer.
- Produce documents for validation and regulatory requirements.
- Organize process and analytical content and help create scalable training programs.
- Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future CTDO operations and products. Communicate this to other staff, as appropriate, and provide key strategic compliance and development input to projects and cross-functional teams, including process and analytical development, manufacturing and technology, BLA preparation, etc…
- Interact extensively with Manufacturing Technology, Process Development, Analytical R&D, Quality Operations, Facilities, Validation, IT and other personnel as dictated by project need.
- Manage project plan and timelines for technical group of ~6 transfer engineers, and supporting staff of operators and analysts.
• PhD in Biological Science, Biomedical Engineering, Chemical Engineering, or related discipline with 5 years development / manufacturing technologies experience, or BS/MS with 10 or more years development / manufacturing technologies for biologics.
• Established track record of success, sound technical qualifications and knowledge in process and analytical transfers. Cell therapy development, manufacturing, and validation experience a plus.
• Solid understanding of the fundamentals of tech transfer.
• Excellent cross-functional skills including work with accountability to multiple stakeholders.
• Strategic thinker with excellent problem solving and conflict resolution skills.
• Ability to foster a strong team-first environment with the ability to lead multiple projects.
• Self-motivation, excellent time management, organizational, written and oral communication skills.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.
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