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.
Senior Director, Apheresis and Manufacturing Operations
Head of Global Apheresis and Manufacturing Operations is responsible for two key elements in the delivery of innovative, life-saving CAR-T therapies: 1) Apheresis center assessment, qualification, contracting, and ongoing GMP operations with those centers, and 2) the design and build of the regional PBMC cell freezing operations, including selecting operating model, building the capacity to meet demand, and qualifying the facilities or mobile units.
Responsibilities will include, but are not limited to, the following:
- Establish and own the operational relationship with hospitals/Apheresis Centers, which are both suppliers of GMP starting raw material and customers of Celgene. This apheresis material consists of patient cells that will then be genetically modified during the manufacturing process to fight cancer.
- Create and lead processes on the selection, approval, certification, qualification of hospitals/sites used to collect (and cryopreserve, if applicable) leukapheresis products. This will include; site feasibility evaluation, creation of site evaluation criteria, collaboration on contracting, identification of site leads, training, oversight of site processes, and implementation of Celgene requirements.
- Implement and maintain clear technical and operational leukapheresis requirements based on Celgene’s specifications within manuals and SOPs.
- Develop internal and external training materials with an emphasis on modularized trainings which align with our mission and strategic plan for CAR-T.
- Establish strong collaborative working relationships within the Commercial teams, Global Clinical Research and Development (GCRD), Global Trial Management/Monitoring (GTMM) teams, Medical Affairs and lTeams to provide scientific and medical input into CAR-T projects and ongoing site needs. Ensure coordinated contact and collaboration is maintained with other line functions (e.g. QA, Clinical, Sourcing, Legal, Supply Chain, Regulatory, Manufacturing Operations).
- Design and build GMP Peripheral Blood Mononuclear Cells (PBMC) isolation and cryopreservation infrastructure and capabilities regionally to support global launches of multiple cell therapy assets, focusing on innovative solutions mobile, brick and mortar, or hybrid solutions
- Provide direction into the user requirements of IT tracking software applications used to manage the CAR-T patient treatment process and coordination of manufacturing and logistics.
- Establish a network/collaboration with internal and external subject matter experts who are able to address potential and immediate leukapheresis and cryopreservation concerns.
- Act as primary point of contact in the field with overall responsibility for ensuring high-quality manufacturing input and coordinating solutions across various Celgene functions
- Design org structure and build team to deliver on responsibilities
- Conduct technical and quality assessments, risk evaluation, coordinate any audits
- Verify Apheresis and PBMC isolation sites apply with all regulations and have capabilities / certifications
- Establish Services Agreement and Quality Agreement
- Establish Celgene required technical specifications
- Train apheresis nurses and cryo labs on Celgene procedures and protocols
- On-site presence when needed (mock/ first collection / first freezing / periodic)
- Perform ongoing on-site assessments and paper based surveillance as needed by risk assessment, coordinate pharma-compliance audits
- Collect KPIs/metrics, monitoring/audit data and perform annual metric reviews
- Work with site to ensure appropriate handling of specimens, questions or issues, changes, deviations
- Perform site decommissioning activities (e.g., investigations, document retention, etc.)
General and Leadership
- Lead as a change agent in fast-paced environment to promote flexibility, creativity, and accountability
- Effectively manage and coach people managers
- Create an environment of teamwork, open communication, and sense of urgency
- Establish clear strategic goals/objectives for the organization that are linked to the overall company strategy
- Drive strong collaboration across the company and with external partners
- Build trust and effective relationships with peers and stakeholders
- Deliver business results through timely and quality decision making
- Foster a culture of high ethics and compliance
- Promote a mindset of continuous improvement, problem solving, and prevention
- B.S. degree, preferably in Science or Engineering
- MBA or Master’s Degree preferable, with at least 10-15 years’ relevant operations experience, including leadership/team building experience
- Biotech or cell & gene therapy experience preferable.
- General GMP Technical Operations experience including some/all of the following: supply operations, logistics, manufacturing, QA, QC and/or other relevant GMP operational functions
- Thorough knowledge of cGMP requirements
- Strong understanding of regulatory requirements for commercial products
- Interaction with health authorities (e.g. FDA, EMEA).
- Participation in GMP or GCP audits as a support or lead auditor
- Strong understanding of risk assessment and risk management fundamentals/tools
- Technical understanding of pharmaceutical processes
- Team and consensus builder, with definitive and authoritative decision making ability
- APICS, CSSP or CPIM certification preferred.
- Previous leadership experience with matrix cross-functional groups
- Excellent interpersonal skills and the ability to communicate well orally and in writing
- Experience operating a multi-product manufacturing plant
- Financial management and budgeting exposure, awareness, and strong acumen
- Ability to balance strategic awareness & direction setting with consistent tactical results
- Previous direct management of multiple functions
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.