Process Lead I
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
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.
We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.
Please submit cv/resume and cover letter to firstname.lastname@example.org. Reference the job title in the subject line of the email
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.