Lead Technician, Operations Jobs in Philadelphia, PA at Iovance Biotherapeutics, Inc.
Title: Lead Technician, Operations
Company: Iovance Biotherapeutics, Inc.
Location: Philadelphia, PA
Salary: $80K — $100K *
Category: Pharmaceuticals & Biotech
Iovance Biotherapeutics is seeking a Lead Technician to join the Operations team for the new Iovance manufacturing site at 300 Rouse Boulevard, Philadelphia, PA. Iovance is an immune-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The companies 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, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company currently is developing its commercial manufacturing capacity to support development and launch of these assets.
As this person will be a lead trainer for 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 current cell therapy manufacturing process, as this role is viewed as a subject matter expert within specific area.
Deliver training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
Assists with identification of training needs, establishing a feedback loop to ensure continuous improvement, and using key performance indicators to measure training effectiveness.
Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of training.
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.
Supports documentation needs, which may including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
Attends the daily lab meeting and escalates issues/concerns at that forum to Area Management for further investigation.
May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Other duties as assigned.
Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
Minimum of 6 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.
Strong knowledge of and experience in in-lab skills training, including aseptic technique and cell culture processing.
Experience leading “development” initiatives, i.e., tra…