About CEL-SCICEL-SCI is a late stage cancer immunotherapy company. CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen for 3 weeks prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body's immune system prior to SOC. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in preparation for the data lock/analysis phase.
The Company's LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment of COVID-19 in hospitalized and at-high-risk patients.
CareersCEL-SCI's success begins and ends with its employees. The Company's progress to date reflects the talent and hard work of the individuals who conduct our lab research, manufacture our drug, manage our clinical trials and support our scientific teams. We are loyal and dedicated. We believe that doing good can also make money. We have persevered against many difficulties and always won. Now we are at the end of the Phase 3 head and neck trial and hope to prove our novel way of treating cancer. If you want to make a difference, join our team.
Equal Opportunity EmployerCEL-SCI is proud to be an equal opportunity employer and extends employment to men and women from culturally diverse backgrounds. We respect and value individual differences and recognize each employee as an integral member of our company. Our work force reflects these values and celebrates the individuals who make up our growing team.
CEL-SCI offers a competitive benefits package which includes:
- Medical insurance
- Dental insurance
- Vision insurance
- Long Term Disability insurance
- Life and AD&D insurance
- 401(k) Plan(each participant's contribution is matched by CEL-SCI with shares of common stock)
- Flexible Spending Accounts – FSA (which allow pre-tax deductions for dependent care, unreimbursed medical expenses and medical premiums).
- Stock Option Plans
- Tuition Reimbursement Plan
- Vacation and Sick Leave
The Raw Materials Associate participates in the routine release of materials required to aid in the manufacturing of Leukocyte Interleukin, Injection (LI) under current Good Manufacturing Practices (cGMP) for clinical application, and facilities operations and maintenance. Required to travel locally to an off-site manufacturing and contract facility. The Raw Materials Associate reports directly to the Manager of Quality Control.
The Quality Control Technical Writer is responsible for writing, reviewing and revising Quality Control documents, including but not limited to protocols, method validations, method qualifications, standard operating procedures (SOPs) and technical reports.
Quality Assurance Auditor performs CGMP audits of documentation supporting the manufacture and testing of a biopharmaceutical drug and audits of suppliers and vendors of materials and services . Reports to the Manager of Quality Assurance
QA/DC position performs filing and archiving of Good Manufacturing Practices (GMP) documents, updating/creating training records, document formatting/revision and other document handling. Reports to the Supervisor of QA/DC
The Facilities/Maintenance Administrator works under the direct supervision of the Facilities Manager. He/She will oversee the management of a safe and efficient working environment essential to the performance of the facility. He/She should have the ability to adapt in a constantly evolving environment and be self-motivated with a strong sense of ownership in areas of responsibility. He/She will be on call 24/7 to respond to facilities matters, security and Environmental Monitoring Systems alarms.
The primary responsibility of the Validation Supervisor is the supervision and hands-on support of developing and implementing validation processes to ensure that the process equipment, procedures and systems used in the manufacture of Leukocyte Interleukin, Injection (LI) meet regulatory requirements, industry standards and cGMP practices.
The Manufacturing Process Technician contributes to the manufacturing team and participates in the manufacture of LI under GMP, and in process development and facilities operations and maintenance. The Manufacturing Process Technician reports directly to Supervisor of Manufacturing.
The Assistant/Associate Immunologist will assist in the day-to-day activities related to the QC testing of Leukocyte Interleukin, Injection (LI) under current Good Manufacturing Practices (cGMP) for clinical application, and QC equipment/facilities operations and maintenance.
The Support Technician contributes to the manufacturing team effort by accomplishing related tasks and assignments. The Manufacturing Support Technician reports directly to Supervisor of Manufacturing.