The company’s lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, and cervical carcinoma.
Non-small cell lung cancer, and immunotherapy for solid tumors. The company currently is developing its commercial manufacturing capacity to support the development and launch of these assets.
As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required.
- 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.
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.
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