Lead Aseptic Manufacturing Specialist

1 week ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time

Iovance Biotherapeutics, Inc. is a pioneering company in the field of immuno-oncology, dedicated to the innovation and commercialization of groundbreaking cancer immunotherapies utilizing tumor infiltrating lymphocytes (TIL). Our flagship product is an autologous, ready-to-administer cell therapy that has shown remarkable effectiveness in treating metastatic melanoma. Currently, we are conducting Phase 2 clinical trials for various cancers, including squamous cell carcinoma of the head and neck, cervical carcinoma, and non-small cell lung cancer, alongside immunotherapy for solid tumors. We are actively enhancing our clinical and commercial manufacturing capabilities to facilitate the development and launch of these vital therapies.

As a crucial member of our autologous cell therapy manufacturing team, candidates should possess a strong background in cell culture, aseptic gowning, and qualification, as well as experience in ISO class 5 cleanroom operations.

Work Shifts:

We offer two rotation options:

  • Shift A:
    Week 1: Sunday to Tuesday, 6:00 PM – 6:30 AM
    Week 2: Sunday to Wednesday, 6:00 PM – 5:30 AM
  • Shift B:
    Week 1: Wednesday to Saturday, 6:00 PM – 5:30 AM
    Week 2: Thursday to Saturday, 6:00 PM – 6:30 AM

Key Responsibilities:

  • Develop a comprehensive understanding of Iovance's GMP cell therapy manufacturing processes and effectively execute and troubleshoot these procedures.
  • Complete all necessary training sessions and maintain accurate training documentation.
  • Ensure compliance with established quality standards and requirements.
  • Provide operational support, including materials management, kit preparation, reagent preparation, and equipment maintenance.
  • Review documentation, including Batch Records and Logbooks.
  • Work according to the assigned schedule, with initial training during standard work hours, transitioning to shifts that may include weekends and holidays.
  • Assist in drafting and approving SOPs, Batch Records, Deviations, and CAPAs, ensuring documentation reflects current practices.
  • Support interdepartmental projects and contribute to technical transfer and research-level testing activities.
  • Participate in daily huddle meetings and escalate any issues to management.
  • Collaborate effectively within a team and independently as required.
  • Perform other duties as assigned.

Basic Qualifications:

  • Bachelor's degree or equivalent experience.
  • Proven technical expertise in aseptic processing within cleanroom environments.
  • Ability to mentor new technicians and share best practices.
  • Adaptability to changing environments and priorities.
  • Proficiency in English, particularly for documentation practices, and familiarity with Microsoft Office applications.
  • Strong mathematical skills for performing calculations.
  • Ability to build credible relationships quickly.
  • Experience in a fast-paced, team-oriented setting.
  • Commitment to Iovance's core values and ethical standards.

Preferred Qualifications:

  • At least 2 years of experience in biopharmaceutical GMP manufacturing, including cell culture and downstream processing.
  • Visual acuity for quality control tasks.
  • Familiarity with regulatory standards and best practices.
  • Proactive and results-driven mindset.
  • Willingness to travel as needed.

Physical and Mental Demands:

  • Ability to wear cleanroom attire and personal protective equipment.
  • Physical capability to stand, walk, and lift up to 45 pounds.
  • Strong problem-solving and analytical skills.
  • Ability to manage stress and prioritize tasks effectively.

Work Environment:

  • Work will be conducted in both office and laboratory settings, with exposure to various chemicals and biohazards.
  • Compliance with safety protocols is essential.

Iovance is committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer, and we welcome applications from all qualified individuals.

  • Lead Aseptic Manufacturing Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewThe Lead Aseptic Manufacturing Specialist plays a crucial role in guiding and overseeing the Aseptic Manufacturing Technician teams. This position necessitates a comprehensive understanding of the theories, techniques, and principles that underpin manufacturing processes. The Lead Specialist will be accountable for leading various tasks,...

  • Lead Aseptic Manufacturing Specialist

    4 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryWe are seeking a highly skilled and experienced Aseptic Manufacturing Team Lead to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for providing guidance and leadership to our Aseptic Manufacturing Technicians, ensuring the smooth operation of our manufacturing processes, and maintaining the highest...

  • Lead Aseptic Manufacturing Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewAs a pivotal contributor to the autologous cell therapy production initiative, candidates should possess a robust background in cell culture, aseptic practices, and ISO class 5 cleanroom operations. Key ResponsibilitiesAchieve a Subject Matter Expert (SME) level of proficiency in executing and troubleshooting GMP cell therapy manufacturing...

  • Senior Aseptic Manufacturing Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Senior Aseptic Manufacturing Specialist RequiredPosition Overview:The Senior Aseptic Manufacturing Specialist plays a crucial role in guiding and overseeing the Aseptic Manufacturing teams. This position necessitates a comprehensive understanding of methodologies, practices, and principles to support the manufacturing processes effectively. The Specialist...

  • Senior Aseptic Manufacturing Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewPosition Title: Senior Aseptic Manufacturing SpecialistSalary: CompetitiveRole Summary:The Senior Aseptic Manufacturing Specialist plays a pivotal role in guiding and overseeing the Aseptic Manufacturing teams. This position demands a comprehensive understanding of methodologies, techniques, and principles essential for supporting manufacturing...

  • Aseptic Manufacturing Specialist

    6 days ago

    Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewR&D Partners is seeking a highly skilled Aseptic Manufacturing Technician to join our team. As a key member of our manufacturing team, you will be responsible for ensuring the quality and integrity of our cell therapy products.Key ResponsibilitiesProcess Execution: Develop a comprehensive understanding of and be able to proficiently execute...

  • Aseptic Manufacturing Specialist

    3 days ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    About the RoleThe Aseptic Manufacturing Technician I position at Planet Pharma is a critical role in our autologous cell therapy manufacturing program. This position requires a comprehensive understanding of theories, techniques, and principles to support manufacturing processes.Key ResponsibilitiesManufacturing Process Execution: Develop a thorough...

  • Aseptic Manufacturing Operations Supervisor

    6 days ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    About the RoleWe are seeking an experienced Aseptic Manufacturing Operations Supervisor to join our team at Planet Pharma. As a key member of our manufacturing operations team, you will be responsible for overseeing the production process, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.Key...

  • Cell and Gene Therapy Manufacturing Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States Proclinical Staffing Full time

    Cell and Gene Therapy Manufacturing Specialist - Contract PositionProclinical Staffing is in search of a skilled Manufacturing Specialist focused on Cell and Gene Therapy. Key Responsibilities:This position is centered on the production of Master and Working Cell Banks, as well as executing tasks within production environments to facilitate the creation of...

  • Aseptic Manufacturing Supervisor

    4 days ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    About the RoleWe are seeking an experienced Aseptic Manufacturing Supervisor to join our team at Planet Pharma. As a key member of our manufacturing operations, you will be responsible for overseeing the production process, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.Key ResponsibilitiesLeadership and...

  • Aseptic Processing Supervisor

    2 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Aseptic Processing SupervisorLocation: Philadelphia, PAShift: Tuesday to Friday, 5:00 PM - 3:00 AM (2nd Shift)Type: Full-Time, SalariedCompensation: $110,000 - $125,000 + bonus + Long-Term Incentive (LTI)Overview:This position is based at our facility in Philadelphia, where you will be responsible for overseeing the production of essential raw materials...

  • Aseptic Processing Supervisor

    2 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Aseptic Processing SupervisorLocation: Philadelphia, PAShift: Tuesday to Friday, 5:00 PM - 3:00 AM (2nd Shift)Type: Full-Time, SalariedCompensation: $110,000 - $125,000 + bonus + Long-Term Incentive (LTI)Overview:This position is located at our Philadelphia facility, where you will be responsible for overseeing the production of essential raw materials...

  • Cell and Gene Therapy Manufacturing Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States Proclinical Staffing Full time

    Manufacturing Associate, Cell and Gene TherapyProclinical is in search of a committed Manufacturing Associate specializing in Cell and Gene Therapy.Key Responsibilities:This position is centered around the production of Master and Working Cell Banks, as well as conducting activities within production environments to facilitate the manufacturing of Cell &...

  • Aseptic Processing Supervisor

    2 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Position: Supervisor, Aseptic ProcessingLocation: Philadelphia, PAShift: Tuesday to Friday, 5:00 PM - 3:00 AM (2nd Shift)Employment Type: Full-Time, SalariedSalary Range: $110,000 - $125,000 + bonus + Long-Term Incentive (LTI)Overview:This position is situated at our Philadelphia facility, where you will be responsible for overseeing the production of...

  • Aseptic Processing Supervisor

    2 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Position: Supervisor, Aseptic ProcessingLocation: Philadelphia, PAShift: Tuesday to Friday, 5:00 PM - 3:00 AM (2nd Shift)Employment Type: Full-Time, SalariedSalary Range: $110,000 - $125,000 + bonus + Long-Term Incentive (LTI)Role Overview:This position is situated at our Philadelphia facility, where the individual will be responsible for overseeing the...

  • Cell Therapy Manufacturing Specialist

    2 days ago

    Philadelphia, Pennsylvania, United States Adaptimmune Full time

    About AdaptimmuneAdaptimmune is a pioneering cell therapy company that has established a strong presence in the biotechnology industry. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.Our CultureOur...

  • Cell Culture Training Lead

    1 day ago

    Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewR&D Partners is seeking a highly skilled and experienced Aseptic Manufacturing Training Supervisor to join our team. As a key member of our organization, this individual will play a pivotal role in overseeing and executing training programs for the aseptic manufacturing team.Key Responsibilities:Oversee and execute training programs for the...

  • Aseptic Production Specialist II

    2 weeks ago

    Philadelphia, Pennsylvania, United States R&D Partners Full time

    Job OverviewThe Aseptic Production Specialist II position plays a vital role in the autologous cell therapy production program. This role demands a comprehensive understanding of methodologies, techniques, and principles essential for supporting production operations.The Production Specialist will undertake various responsibilities, including cleaning,...

  • Lead Cell

    4 weeks ago

    Philadelphia, Pennsylvania, United States Proclinical Full time

    Proclinical is seeking a Lead Manufacturing Associate who will be responsible for the production of M&W Cell Banks. The role also involves supporting the manufacturing of Cell & Gene Therapy products and final product fills in accordance with current Good Manufacturing Practices (cGMPs).Please note that to be considered for this role you must have the right...

  • Expert Aseptic Process Technician

    2 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time

    Iovance Biotherapeutics, Inc. is at the forefront of immuno-oncology, dedicated to pioneering and commercializing innovative cancer therapies that leverage tumor infiltrating lymphocytes (TIL). Our flagship product is a personalized, ready-to-administer cell therapy that has shown remarkable effectiveness in treating metastatic melanoma. We are currently...