Associate Manager, CMC CAR-T
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.Associate Manager, CMC CAR-TWarren, NJ
The primary responsibility of this role is to release CAR T products manufactured by CMOs to support clinical trials in Europe and Asia-Pacific in collaboration with QA. The successful candidate will be required to use advanced cell therapy expertise and CMC technical expertise to support CAR T product release partnering with QA. The candidate will be also responsible for reviewing the CMO process validation documents and CMC documents for regulatory filing. This qualified candidate should have extensive process knowledge & working experience. The candidate will also work closely with Global Quality Operations team and provide them with necessary process development support.
This position will involve extensive interaction with collaboration partners' such as technical & quality teams and collaboration within cross-functional Celgene teams in order to support CAR T global clinical trials and advance rapid commercialization of CAR T therapies. Responsibilities will include, but are not limited to, the following:
- Review manufacturing batch records and product associated documents for clinical CAR T product release partnering with QA.
- Review analytical data for clinical CAR T product release.
- Manage deviations/OOS/CAPA in Celgene compliance system for clinical CAR T product release.
- Generate Certificate of Analysis (CoA) for CAR T clinical product release.
- Manage change control through impact assessments, tracking and implementation in Celgene compliance system.
- Tracks and reports performance metrics as required.
- Interface with contract manufacturers and testing laboratories to communicate and promptly resolve product issues.
- Manage all project-related documentation (all SOPs, important technical reports, etc.) in Celgene's documentation system and manage the version change.
- Knowledge of process validation strategies to review CMO validation reports
- Provide necessary technical support to Celgene Quality Operations (quality document review, audit support, risk assessment, etc.)
- Serve as an advanced manufacturing and product quality SME from CMC in cross-functional teams and support execution of process operational strategies.
- Interact with other CMC teams, Quality operation, Clinical Operation, Regulatory and other personnel as dictated by project need. Contribute in a team-oriented environment to achieve common project goals.
- Interact with CMOs, collaboration partners, consultants, and national Celgene affiliates to ensure alignment around regulatory requirements and resulting operational design and regulatory submissions.
BS in relevant science or engineering field with minimum of 8 years of pharmaceutical experience or MS with minimum of 6 years of pharmaceutical experience preferred. Experience in cell therapy or Biologics preferred.
- Technical expertise of process development and validation
- Knowledge of cGMP/FDA regulated industry
- CMC experience within a development/GMP operations facility
- Knowledge and technical expertise of process development in cell therapy or biologics.
- Technical writing capability
- Implement metrics to track and manage completion of objectives and projects
- Knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance.
- Excellent organization, verbal and written communication and presentation skills.
- Strong interpersonal skills and the ability to work in cross-functional teams effectively and interacting with external collaborators to build strong relationship.
- Experience with Quality Organization at a Production Center is a big advantage.
- Willingness to travel 5-10%.
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.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.