Manager, Apheresis - Immuno - Oncology - Regionally Based
Other Locations:US- NJ- Warren
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.Apheresis ManagerWarren, NJ -or- Regionally based from a home office.
Immuno - Oncology and CAR-T tie in.
Willingness to travel, domestically (up to ~50% of time)
This position has the overall responsibility of 1. ensuring a high quality and consistent supply of cellular starting material intended for use in GMP cell manufacturing of autologous cell therapy products and 2. ensuring consistency and control of final product handling and preparation before administration. The Apheresis Manager will be involved in the evaluation, training, and technical support of sites that will collect this cellular starting material as well as sites that will administer the final product to the patient.
- Lead the on site evaluation of collection centers' capabilities and work flow and verify that they comply with all applicable regulations and accreditations.
- Develop and maintain relationships with a network of apheresis centers.
- Perform site initiation activities such
as on site apheresis training that details product-specific requirements, on site technical support for first collections, and refresher trainings as needed.
- Monitor apheresis sites to ensure consistency in collections and manage any exceptions.
- Respond and manage collection related issues by troubleshooting, follow-up, and suggesting/implementing improvements as needed.
- Communicate all critical issues that may affect manufacturing, timelines, or quality to the appropriate departments.
- Collect and monitor apheresis data for trends and provide to Process Development.
- Review and provide input for revision of collection parameters as needed based on data review.
- Provide documentation of all site interactions, including site visit reports.
- Actively communicate with apheresis centers involved in trials to facilitate patient scheduling and ensure uninterrupted patient enrollment.
- Collaborate cross-functionally to ensure transparency between departments such as QA, clinical operations, and manufacturing that are affected by apheresis collections and timelines.
- Collaborate with the Supply Chain department to ensure traceability of apheresis through manufacturing to product infusion.
- Provide input in the development of strategic plans and systems for increased clinical and commercial forecasts.
- Undergraduate degree in life sciences or engineering. Advanced degree in the life sciences (e.g. PharmD, NP, PA, RN) preferred.
- Experience collecting cells via apheresis, blood donation centers, etc preferred.
- Prior customer- facing role in pharmaceutical industry - 5 years.
- Knowledge of applicable regulations and standards (AABB, FACT JACIE).
- Knowledge of GCP and ICH Guidelines.
- Detail-oriented, well-organized.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Demonstrated ability to work as part of a team.
- Ability to interface cross-functionally with clinical, quality, and development personnel.
- High level of interpersonal and communication skills (written and verbal).
- Ability to work independently.
- Willingness to travel, domestically (up to ~50% of time) .
#LI-POSTCelgene 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.