About CEL-SCI

CEL-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 its Phase III study in advanced primary head and neck cancer patients CEL-SCI treated patients who are newly diagnosed 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 III study is the largest Phase III 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.

Topline results: The Phase III study in newly diagnosed advanced primary head and neck cancer with our Multikine immunotherapy produced a statistically significant 5-year survival benefit in patients receiving surgery plus radiotherapy. These patients represent about 40% of the study population and approximately 210,000 patients annually worldwide. The 5-year overall survival (OS) benefit in this study treatment arm was robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation) Multikine arm 62.7% control arm 48.6%, survival.
 
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.

Careers

CEL-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 Employer

CEL-SCI is proud to be an equal opportunity employer and extends employment to both women and men 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
  • AFLAC

Available Positions

Quality Assurance Document Control (QADC) Manager

Department:  Quality Assurance

Quality Assurance Department is a support group to the Operational Departments of Manufacturing, Validation, Quality Control, R&D, Warehouse, and Facilities. The Quality Assurance Document Control Manager is responsible for performing technical functions in the QADC group, manages the daily operations of the QADC staff, and interacts with each group to ensure accurate and compliant documents are produced. This role ensures compliance of SOPs, policies, and procedures. This position reports to the Quality Assurance Director.

Education & Experience:

  • Bachelor's degree in a relevant scientific discipline or equivalent work experience.
  • In-depth knowledge of cGMP and regulatory requirements applicable to the pharmaceutical, biotechnology, or related industries.
  • Experience working in FDA regulated environment a plus.
  • 8+ years’ experience in a related GMP environment.

Skills & Abilities:

  • Proficient knowledge of document control electronic systems (MasterControl preferred).
  • Strong knowledge of Microsoft Word, Excel, Outlook, PowerPoint, Access, and Adobe Acrobat.
  • Strong technical writing and editing skills.
  • Strong organization, presentation, and facilitation skills while paying attention to detail.
  • Strong people management skills
  • Excellent verbal and written communication skills.
  • Ability to work independently and in cross functional team in a collaborative manner.
  • Knowledge and experience with cGMP practices.
  • Thorough knowledge and understanding of quality systems.
  • Ability to lead project teams and work collaboratively to drive right first-time initiatives.
  • Ability to work in a dynamic and fast paced environment.

Responsibilities:

  • Develop and implement document control policies and procedures to ensure compliance with industry standards and regulatory requirements.
  • Quality check all documents for conformance to plans, EDMS requirements.
  • Verify the accuracy and completeness of cGMP documents.
  • Follow Policies and SOPs to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
  • Maintain all GMP documents in a secure manner at all times.
  • Serves as the Electronic Document Management System (eDMS) administrator, maintains and implements eDMS processes; partners with Validation to manage/maintain change control and validation documentation for eDMS.
  • Coordinate with document originators and/or stakeholders to resolve document control issues to obtain final approval/ensure smooth operation of all functions.
  • Manage the organization of controlled document files within the Document Control center and ensure that records are readily retrievable.
  • Ensure all controlled documents follow regulatory requirements, including FDA and international guidelines.
  • Maintain employee training records, document master files, authorized signature forms according to company procedures, industry best practices, and government regulations.
  • Carry out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
  • Ensure adherence to cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements throughout the manufacturing process.
  • Identify opportunities for process improvements and contribute to the development and implementation of enhancements.
  • Organize timelines, schedules, and resources to ensure project milestones are met.
  • Conduct risk-based investigations through using problem solving tools.
  • Authors, reviews, and approved data/documents such as methods, procedures, policies, and/or protocols.
  • Track/Report metrics/KPIs for quality activities to leadership teams as needed.
  • Provide training/presentations as needed.
  • Provide scheduled, structured training for all users of the EDMS, both internally and externally
  • Support regulatory audits and inspections with respect to requested training and documentation needed.  Assist in audit preparation.
  • Communicate and coordinate with other departments to ensure training and quality compliance.
  • Be familiar with the day-to-day activities, personnel, and issues within the facilities.
  • Stays current with latest industry trends, tools, and best practices, bringing forth new ideas and challenging status quo.
  • Assist the Quality Assurance Management in daily operations, as needed.
  • Manage subordinate staff in the day-to-day performance of their jobs.
  • Performs other related duties as required and/or assigned.

WORK HOURS:

Position is full time.

Monday through Friday – 8:00-4:30 (with 30-minute lunch or 8:00-5:00 (with 1 hour lunch) 

LOCATION:

This is an onsite position at our Elkridge, MD site with some travel to the Seton facility (20 minutes North).

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options. 

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email 

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Quality Assurance Document Control (QADC) Manager Department:  Quality Assurance Quality Assurance Department is a support group to the Operational Departments of Manufacturing, Validation, Quali...

Posted 9 months ago

Process Lead I

Department:  Manufacturing

The Process Lead participates in the manufacture of Leukocyte Interleukin, Injection (LI) under cGMP for clinical application, and facilities operations and maintenance.  The Process Lead reports directly to the Supervisor of Manufacturing.

Education & Experience:

  • B.S. and 5+ years experience in related field

Skills & Abilities:

  • Understanding and awareness of current Good Manufacturing Practices (cGMP) and basic familiarity with FDA and EU Guidelines
  • Able to follow Standard Operating Procedures (SOP’s)
  • Familiarity with MasterControl and associated requirements for creating and revising controlled documents
  • Able to follow Master Batch Record when performing LI manufacture process steps
  • Able to work in an ISO classified work environment
  • Demonstrates good aseptic technique and ability to work in a biological safety cabinet
  • Participate in required safety, GMP, and technical training sessions
  • Coordinate training of newly hired or existing staff
  • Training of newly hired staff
  • Provide technical assistance to junior and new staff
  • Contact vendors regarding new supplies or changes to existing supplies
  • Troubleshoot minor problems that may occur during LI manufacture process in communication with management

Responsibilities include, but are not limited to:

  • Participate in the manufacture of clinical LI
  • Under direction from the Manufacturing Supervisor, Manager or Director, assist in the coordination and delegation of activities of junior staff in a specific process area
  • Provide guidance to junior staff requiring process knowledge and experience
  • Troubleshoot minor problems with the manufacturing process
  • Proposes Changes to methods, design, or equipment
  • Coordinate training of newly hired employees and current employees, if needed
  • Requisition materials from warehouse needed for processing and for support work
  • Clean, sanitize and monitor equipment, as assigned
  • Troubleshoot problems with equipment
  • Draft, revise and process various SOP’s and other related documents
  • Able to follow and complete Batch Record
  • Review completed Batch Records and forms prior to submission for compliance and accuracy
  • Accurately and promptly complete timesheets / other required paperwork
  • Attend and contribute to departmental and general staff meetings         

WORK HOURS:

Position is full time.

Monday through Friday with occasional Saturday work required. Normal business hours are 8:00 AM to 5:00 PM.  Occasional weekend and evening work will be required. 

LOCATION:

Elkridge, MD. 

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options. 

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email 

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

The Process Lead participates in the manufacture of Leukocyte Interleukin, Injection (LI) under cGMP for clinical application, and facilities operations and maintenance.

IT Specialist - GMP Systems

Department:  Operations

The IT Specialist - GMP Systems is responsible for supporting a broad range of needs related to CEL-SCI’s GMP IT infrastructure and the use of electronic devices (i.e., desktop computers, laptop computers, network servers, tablets) that support the manufacturing and testing of our cancer immunotherapy, Multikine, as well as working with the Company’s IT consultant. Digital information assessed by, created by, and stored by CEL-SCI is highly confidential and must be protected from all outside parties.  As a biopharmaceutical company making a complex biological drug, the IT Specialist will ensure that CEL-SCI follows Current Good Manufacturing Practices (cGMP) as outlined in the US Code of Federal Regulations (CFR) Title 21 Parts 210 and 211, Part 11 and European Union (EU) Annex 11.0.  The IT Specialist reports to the Operations Department with its primary role to support the validation department during the GMP computer systems validation efforts.

Requirements:

Education & Experience:

  • Bachelor’s degree or equivalent college level training, Computer Science degree preferred
  • 5+ years’ experience in a pharmaceutical/biopharmaceutical environment
  • Knowledge of FDA Title 21, Parts 210 and 211 cGMP (Current Good Manufacturing Practices), Part 11 (Electronic Records/Electronic Signatures) and EU Annex 11 (Computerized Systems)

Skills & Abilities:

  • Strong understanding of Computer System GMP regulatory requirements (21 CFR Part 11, Annex 11)
  • Strong technical writing and editing skills to draft IT Program Documents that support GMPs
  • Capability to suggest and implement working solutions that meet cGMP computer system compliance
  • Ability to administer multiple systems simultaneously
  • Comfortability to work in a team environment to meet project deadlines
  • Excellent communication skills
  • Strong organizational skills
  • Strong inventory tracking skills

Technical Competencies:

  • Strong knowledge and abilities in Microsoft Office Applications
  • Strong knowledge of Windows OS
  • Strong Knowledge of Windows Server 2016 and newer
  • Work experience setting up new Windows server from start to finish
  • Strong knowledge of Active Directory, DHCP, DNS, Group Policy
  • Strong knowledge of router/firewall configuration and maintenance
  • Work experience with Cisco, Sonic Wall, and/or Ubiquiti router/firewall is a plus
  • Strong knowledge of TCP/IP protocol
  • Entry level knowledge of cloud solutions like Microsoft Azure
  • Entry level knowledge of various computer programming languages 
  • Knowledge of SQL Server and SQL programing is a plus

Responsibilities include, but are not limited to:

  • Develop IT policies, Standard Operating Procedures (SOPs), and data storage requirements that fit within the overall GxP strategy and support quality standards to ensure compliance with regulatory guidelines
  • Initiate, assess, implement, and approve change controls as they relate to IT and GMP computer systems
  • Provide IT technical review for Standard Operating Procedures (SOPs), Computer Systems Validation (CSV) protocols, equipment specifications, etc., as appropriate
  • Implement system securities and user access management restrictions to ensure data integrity
  • Perform Data Integrity assessments and remediations for GMP computer systems periodically
  • Develop a robust back-up and restoration program for GMP-relevant systems that reside at multiple locations
  • Collaborate within a team environment to ensure appropriate documentation of IT responsibilities throughout the CSV process
  • Assist in the maintenance of a computer system inventory in accordance with the Computer System Validation Master Plan (VMP)
  • Troubleshoot issues with computer systems during GMP manufacturing activities
  • Train employees on IT procedures applicable to the GMP manufacture and testing
  • Support the IT consultant in building  or repair network hardware and infrastructure
  • Recommend IT purchases as needed
  • Provide help desk services to employees
  • Administer GMP computer systems to ensure alignment with GMP policies and procedures
  • Assist the IT consultant with  local workstation permission settings, periodic review and back-up
  • Other duties as assigned

Other:

  • Ability to stand, walk, and sit for hours
  • Ability to work in tight environments with little room for maneuvering
  • Ability to lift up to 50 LBS

Work Hours:

Position is full time. Monday through Friday.  Occasional evening and weekend work may be required.  Travel to the R&D laboratory facility in Baltimore, MD (20 minutes north) will be required.  Must be able to work non-standard hours (weekends, evenings, nights) as needed.

Location:

Elkridge, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options. 

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email 

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

The IT Specialist - GMP Systems is responsible for supporting a broad range of needs related to CEL-SCI’s GMP IT infrastructure and the use of electronic devices

Validation Technician

Department:  R&D and Validation

The Validation Technician is responsible for supporting validation activities of GMP equipment and systems.  Assists in specifying and selecting equipment. Maintains all records related to qualification and validation.  Prepares validation reports, suggests, and assists in determining specifications, and makes recommendations for modifications as necessary.  The Validation Technician reports to the Validation Engineer.

Education/Experience:

  • B.S. in science or engineering or a related discipline
  • 2-year degree and 1 to 2+ years of relevant experience
  • No degree and 2 to 4 years of relevant experience

Skills/Abilities:

  1. Demonstrates knowledge of Standard Operating Procedures (SOPs)
  1. Demonstrates knowledge of Good Manufacturing Practice (GMP)
  2. Develop technical expertise in reference to the Kaye validator
  3. Participate in required safety, cGMP, and technical training sessions

Responsibilities include, but are not limited to:

  1. Collects and analyzes validation data for temperature controlled units
  2. Perform commissioning, qualification and validation activities
  3. Recommends equipment operation specification changes
  4. Collects data and prepares preliminary reports
  5. Assist in equipment maintenance activities
  6. Explore problems that occur and suggest appropriate solutions
  7. Draft/revise GMP documentation including SOPs, Testing Standards, Specifications, Training Guidelines

WORK HOURS:

Position is full time.

This position requires local travel between CEL-SCI Facilities

LOCATION:

Baltimore & Elkridge, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.  

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email  

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

The Validation Technician is responsible for supporting validation activities of GMP equipment and systems. 

Position:  Human Resource (HR) Manager Department:  Operations The Human Resource Manager will lead the routine functions of the Human Resources (HR) department including hiring and interviewing staff and ensuring that company policies and practices are being followed.  The HR Manager will work closely with the Director of Operations and report to the Senior Vice President of Operations. Education and Experience:  
  • Bachelor’s degree in Human Resources, Business Administration, or related field required.
  • A minimum of 7-10 years of human resource management experience preferred.
  • SHRM-CP or SHRM-SCP highly desired.
Skills/Abilities:
  • Working understanding of human resource principles, practices and procedures
  • Excellent verbal and written communication skills 
  • Excellent interpersonal and customer service skills
  • Excellent time management skills with a proven ability to meet deadlines 
  • Excellent organizational skills and attention to detail
  • Strong analytical and problem-solving skills
  • Ability to act with integrity, professionalism, and confidentiality
  • Experience in hiring and managing shifts
  • Proficient with Microsoft Office Suite and Human Resources Information System (HRIS) software (i.e., ADP)
Duties/Responsibilities:
  • Manages the talent acquisition process, which includes recruitment, interviewing, and hiring of qualified job applicants; collaborates with departmental managers to understand skills and competencies required for openings, work with outside recruiters
  • Ensure new hire paperwork is completed and processed
  • Assist in employee orientation, development, and recordkeeping
  • Assist with compensation and benefits administration and recordkeeping
  • Preparing and/or updating employment records related to hiring, transferring, promoting, and terminating
  • Assist in ensuring that HR policies, procedures and corporate culture are related clearly to new and existing employees
  • Assists in the administration of company benefit plans, including enrollments, changes and terminations
  • Assists with the preparation of the performance review process
  • Analyzes trends in compensation and benefits; researches and proposes competitive base and incentive pay programs to ensure the organization attracts and retains top talent.
  • Creates learning and development programs and initiatives that provide internal development opportunities for employees 
  • Assist with employee disciplinary meetings, terminations, and investigations.
  • Maintains compliance with federal, state, and local employment laws and regulations, and recommended best practices; reviews policies and practices to maintain compliance.
  • Maintains knowledge of trends, best practices, regulatory changes, and new technologies in human resources, talent management, and employment law.
  • Performs other duties as assigned.
Work Hours:   Position is full time. Ability to work flexible schedule if required. Location:  Elkridge, MD. The position will require travel to our Baltimore, Maryland location as well as to Vienna, VA the corporate headquarters as needed.  We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.   Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email   DISCLAIMER: CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

The Human Resource Manager will lead the routine functions of the Human Resources (HR) department including hiring and interviewing staff and ensuring that company policies and practices are being fol...