Assistant Immunologist I

Department:  Bioassay (BA)

The Assistant Immunologist I participates in the preparation of all media to support cell growth, performance of biological assays necessary for testing Leukocyte Interleukin, Injection (LI), facility operations and maintenance while following SOPs and maintaining GMP compliance.  The Assistant Immunologist reports directly to the Bioassay Manager.

Education & Experience:

• A.A. and 2+ years experience (or equivalent experience in related field)
• B.S. and 0-2 years experience (or equivalent experience in related field)

Skills & Abilities:

• Develops awareness of Standard Operating Procedures (SOP)
• Develops awareness of Good Manufacturing Practices (GMP)

Responsibilities include, but are not limited to:

1. Prepare cell culture media
2. Performance in culturing of cell lines
3. Perform Cell Based Proliferative Assays
4. Complete Radiation Safety Training
5. Participate in required safety, GMP, and technical training sessions
6. Help maintain and monitor laboratory equipment 
7. Organize and monitor inventory and supplies, as requested
8. Assist in the packaging and shipment of equipment, per SOP
9. Maintain accurate equipment inventories.
10. Maintain up to date SOP and MSDS binders.
11. Stock laboratory and assist in cycle counts and annual inventory
12. Comply with company guidelines for document control 
13. Draft/Revise SOP’s, Testing Standards, Specifications, Administrative Instructions, Training Guidelines, and other documentation
14. Maintain proper GMP documentation during all laboratory work.
15. Review completed assay files prior to submission
16. Audit files after archival
17. Assist in archiving Bioassays records
18. Draft simple protocols and reports

WORK HOURS:

Position is full time. Weekend, holiday, and evening work to be assigned on a rotating basis, as needed.

Limited local travel to other Company facilities may be required.

LOCATION:

Baltimore, MD

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

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

Manufacturing Process Technician I

Department:  Manufacturing

The Manufacturing Process Technician contributes to the manufacturing team and participates in the manufacture of CEL-SCI’s lead product, Leukocyte Interleukin, Inj. (LI) following cGMPs.  Also, process technicians may participate in process development and validation activities, equipment qualification and/or equipment maintenance and calibration.  The Manufacturing Process Technician reports directly to Manufacturing Management.

Education & Experience:

• High School Diploma and certification through accredited biotechnology instruction and 2+ years relevant experience
• AA Degree in a related field and 1+ years relevant experience 
• BS/BA Degree in a related field

Skills & Abilities:

• Understanding and awareness of current Good Manufacturing Practices (cGMP) 
• Basic familiarity with FDA and EU Guidelines
• Able to follow Standard Operating Procedures (SOPs)
• Able to follow Master Batch Records
• 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

Responsibilities include, but are not limited to:

• Participate in the manufacture of clinical/commercial LI
• Submit QC test samples
• Maintain inventory of all processing rooms 

• Monitor equipment performance parameters
• Clean and sanitize equipment after use 
• Complete required log books and forms for equipment
• Check calibration status prior to use 

• Review completed Batch Records and forms prior to submission
• Familiarity with Quality Management Systems

WORK HOURS:

Position is full time. Weekend, holiday, and evening work to be assigned on a rotating basis, as needed.

Limited local travel to other Company facilities may 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.

Validation Engineer

Department:   R&D and Validation 

The Validation Engineer is responsible for the regulation and support of equipment and systems. Assists in equipment selection, specification, and negotiating fees. Maintains all records related to qualification and validation. Works on projects where data analysis requires evaluation of defined factors to broad concepts. Utilizes independent judgment within broad parameters to determine an appropriate solution.  Prepares validation reports, suggests and assists in determining specifications, and makes recommendations for modifications as necessary.  The Validation Engineer reports to the Validation Supervisor.

Education/Experience:

• B.S. in science/engineering field and 1 to 2 years of equipment qualification/validation experience 

Skills/Abilities:

• Ability to understand and demonstrate knowledge of Standard Operating Procedures (SOPs).
• Demonstrates knowledge of Good Manufacturing Practice (GMP) and FDA 21 CFR 210/211/820, EU GMP Annex 1, ICH guidelines.
• Hands-on experience with Kaye validator and temperature mapping.
• Soft skills such as technical writing, good communication skills, root-cause investigation and cross-functional coordination skills, detail-oriented mindset.

Responsibilities include, but are not limited to:

• Author I/O/PQ protocols, periodic review documents, specifications, SOPs and summary reports.
• Maintain and execute equipment periodic review activities for various 

departments equipment and systems including Facilities, Environmental Monitoring, Bioassay, Manufacturing and Quality Control. 

• Co-ordinate with various departments and stakeholders to gather information and documentation related to the equipment and systems. 
• Assist in specifying and selecting equipment.  Maintains all records related to qualification and validation.  
• Prepare periodic review and validation summary reports and make recommendations for modifications as necessary.
• Initiate and maintain Deviation and CAPA activities and perform any corrective actions as needed. 

WORK HOURS:

Position is full time. 

This position may require periodic local travel between CEL-SCI Facilities, to contract facilities, and to external Validation providers.  

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.

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.