Lead Aseptic Manufacturing Technician - Night Shift

at  Iovance Biotherapeutics Inc

IOVANCE IS HOSTING AN ONSITE JOB FAIR.

Where: Iovance Cell Therapy Center (iCTC)
Location: 300 Rouse Blvd Philadelphia, PA 19112
Date: Wednesday, October 23, 2024
Time: 12pm to 6pm (EDT)
What to bring: Updated hard copy resume

REQUIRED EDUCATION, SKILLS, AND KNOWLEDGE

• Bachelor’s degree or some post-secondary education.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to other team members.
• Must be able to work with ambiguity – ready to change gears and plans quickly and manage constant change.
• Must be able to read, write and understand English for Good Documentation Practices
• Proficient with computers and Microsoft (Excel, Word, Outlook) programs.
• Ability to perform arithmetic calculations accurately and reproducibly, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
• Ability to build relationships quickly and credibly.
• Ability to work successfully in a fast-paced, team-oriented environment.

PREFERRED EDUCATION, SKILLS, AND KNOWLEDGE

• 3+ years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulatrion
• Proactive, results-oriented, self-starter with experience in a complex manufacturing environment
  The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

• Develop a Subject Matter Expert (SME)-level understanding of and can execute as skillfully as well as troubleshoot Iovance’s GMP cell therapy manufacturing process(es).
• Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
• Deliver training sessions and ensure training documentation is maintained.
• Understand and comply with quality standards and requirements as documented. Ensure training schedules meet company production and quality targets.
• Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
• Perform document review, including executed Batch Records and Logbooks.
• Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to reflect current procedures accurately.
• Execute documentation Change Controls of SOPs, Batch records, etc., as needed.
• Support interdepartmental and departmental projects in a contributor capacity.
• Supports technical transfer and additional research-level testing activities as needed.
• May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
• Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Completes recording of data to comply with regulatory requirements.
• Attend or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
• Ability to work in a team environment and independently as required.
• Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
• Work in a cleanroom with biohazards, human blood components, and chemicals
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.
  Travel – 5%