Position: QA Manager

Department:  Quality Assurance

Description:  Quality Assurance is a support group to the Operational Departments of Manufacturing, Quality Control, Warehouse, and Facilities. The Quality Assurance Manager is responsible for managing daily operations of the QA staff, performing technical functions in the Quality Assurance group and interacts with each group to ensure accurate and compliant documents are produced and release of intermediates and final product. This role ensures compliance of SOPs, policies, forms, and procedures. Primary functions will be but is not limited to managing daily operations of the QADC staff, investigating non-conformances, performing risk assessments, reviewing protocols and reports, trend evaluation and reporting, technical review of critical procedures and processes, coordinate process changes, support regulatory inspections, assist with regulatory responses, and develop and implement process improvements.  This position reports to the Quality Assurance Director.

REQUIREMENTS:

Education and Experience:

• Bachelor's degree in a relevant scientific discipline or equivalent work experience.
• In-depth knowledge of cGMP and regulatory requirements (US and EU) applicable to the pharmaceutical, biotechnology, or related industries.
• Experience working in FDA regulated environment required.
• Experience with regulatory inspections required.
• 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.
• Ability to gown into clean rooms including ISO 5.

Responsibilities:

• Manage subordinate staff in the day-to-day performance of their jobs.
• Assist Quality Assurance Management in daily operations.
• 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.
• 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.
• Review and approval of qualification activities, quality records like deviations OOS, complaints, auxiliary forms, investigations, procedures and other quality related documentation.
• Create and maintain risk assessments to ensure program/project risks are identified, assessed, mitigated, and closed.
• Perform technical review of Quality Control testing data against established specifications.
• Assist with the receipt and processing of Supplier Change Notifications.
• Manage the receipt, investigation, and closure of product complaints, supplier complaints, and adverse events.
• Manage timely review and release of raw materials and consumables to maintain the production schedule.
• Manage and performs QA on the Floor activities, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing.
• Schedule, plan, conduct, and compile detailed reports for internal and supplier audits.
• Ensure adherence to cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements throughout the batch record review process.
• Work directly with all departments to provide process oversight and to support them in ensuring compliance.
• Investigate any discrepancies identified. Reviews quality records (deviations, CAPAs, change controls, out of specifications) and collaborate with relevant departments to address and resolve issues promptly.
• Carry out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies.
• Ensure adherence to cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements throughout the manufacturing process.
• Identify opportunities for process improvements and contribute/lead 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.
• Author, review, and approve data/documents such as methods, procedures, policies, and/or protocols. 
• Oversee development and tracking of metrics/KPIs for quality activities.
• Provide training/presentations as needed.
• Provide scheduled, structured training for all users of the eDMS, both internally and externally.
• Conduct Quality-focused training sessions to educate team members on quality programs, documents, and best practices.
• Support regulatory readiness of the organization and participate in regulatory audits and inspections. 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.
• Remain current with latest industry trends, tools, and best practices, bringing forth new ideas and challenging status quo.
• Performs other related duties as required and/or assigned.

Work Hours:  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 travel to the Seton facility (20 minutes North) as needed.

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.  

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.

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  

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.

Analytical Research Associate 

Department:   R&D and Validation 

Analytical Research Associate participates in various research, development, and validation activities for new and existing analytical methods. Duties may include evaluation of new and existing methods, development of new and existing methods, and validation of new or updated methods. The Analytical Research Associate reports to the R&D Manager and/or the Senior Director of R&D and Validation.

Education and Experience:

• B.S. and 2 years’ experience (or equivalent experience in related field)
• Experience in research or clinical laboratory 
• Experience in assay development / troubleshooting, bioassays, cell culture, ELISA, PCR, and other analytical methods preferable

Skills/Abilities:

• Demonstrates knowledge of Standard Operating Procedures (SOP)
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment
• Performance of various analytical methods
• Strong data analysis 
• Strong organizational skills and attention to detail, with the ability to multitask and switch tasks effectively
• Strong technical writer  

Responsibilities include, but are not limited to::

• Responsible for executing research and development activities under direct supervision
• Responsible for executing validation activities in support of QC under direct supervision

• Perform analytical methods experiments
• Collects data and prepares preliminary reports
• Maintains files for R&D and validation documentation
• Assist in laboratory and equipment maintenance activities
• Draft/revise R&D and GMP documentation including SOPs, Forms, and Reports 

Work Hours:  

Position is full time, on site.  Monday through Friday - 8:00–5:00 (with 1 hour lunch) or 8:30–5:00 (with 30-minute lunch).  Occasional early and late work may be required.

Location: 

North 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  

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.