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.

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.

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)

2. Demonstrates knowledge of Good Manufacturing Practice (GMP)
3. Develop technical expertise in reference to the Kaye validator
4. 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.

Validation Engineer

Department:  Research and Development

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 a related discipline and 1 to 5+ year of relevant experience
• M.S. in a related discipline and 2 to 4 years of relevant experience
• Ph.D. in a related discipline and 1 to 2 years of relevant experience

Skills/Abilities:

1. Demonstrates knowledge of Standard Operating Procedures (SOPs)

2. Demonstrates knowledge of Good Manufacturing Practice (GMP)
3. Train new staff, as available
4. Provide technical and project guidance to junior staff
5. Participate in required safety, cGMP, and technical training sessions

Responsibilities include, but are not limited to:

1. Performs, collects and analyzes simple validation data
2. Collects and prepares preliminary reports
3. Explore problems that occur and suggest appropriate solutions. 
4. Maintains files for validation documentation (i.e., IQ, OQ, PQ, and all other product changes)
5. Routine maintenance of the R&D and manufacturing laboratory
6. Draft/revise SOP’s, Testing Standards, Specifications, Training Guidelines, and other documentation

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.

• 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.

• 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)

• 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.

• B.S. and 7+ years experience with 2+ years supervising (or equivalent experience in related field)

• Ensure the timely receipt of QC samples
• Ensure the timely testing LI cell culture supernatant, bulk solution, formulated LI drug solution and finished product (per LI Master Batch Record, MBR
• Participate in the testing of LI cell culture supernatant, bulk solution, formulated LI drug solution and finished product, as needed
• Co-ordinate QC testing during formulation of LI drug in contract manufacturer’s facility
• Troubleshoot problems with QC testing assays
• Provide on-site supervision of the LI QC testing activities
• Establish QC trends and develop control charts

• Testing of components, reagents, media, and chemicals, as needed
• Oversee the release of quarantined items
• Trouble shoot problems with raw materials testing
• Review and revise existing QC methodologies in support of raw materials testing
• Identify, evaluate, and meet with contract testing laboratories to discuss new or modify existing testing methods
• Routine maintenance of QC equipment