• Develop a comprehensive understanding of and be able to proficiently execute Iovance’s current cell therapy manufacturing process.
• Complete training sessions and ensure training documentation is maintained.
• Understands and complies with quality standards and requirements as documented.
• Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
• Supports technical transfer and additional research-level testing activities.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to reflect current procedures accurately.
• Attends the daily lab 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.

Skills:

GMP, production, cell culture, cGMP, aseptic, protein purification, upstream process, Downstream, AKTA, Unicorn Software, Bioreactor

Top Skills Details:

GMP,production,cell culture,cGMP,aseptic,protein purification,upstream process,Downstream

Additional Skills & Qualifications:

• Minimum B.S. degree in biology, biochemistry, bioengineering, related technical field, or equivalent industry experience.
• Minimum of 1+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to mentor and provide best practices to other members of the team.
• Ability to build relationships quickly and credibly.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages, and basic algebraic and geometric calculations.
• Proactive, results-oriented, self-starter with experience in a complex manufacturing environment.
• Ability to work successfully in a fast-paced team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
• Aseptic Manufacturing Technicians are required to work their assigned schedule. This position is currently for regular work week hours (1st shift M-F); however, due to the nature of cell therapy manufacturing schedules. You must be willing to work alternative shifts, weekends, evenings, and holidays, as needed.
• It is also expected that regular work weeks may change once commercial manufacturing commences and may involve shift changes (i.e. Tuesday to Saturday). May be required to work overtime.

Experience Level:

Intermediate Level

About Actalent:

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