Microbiology Quality Control Training Specialist

2 weeks ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Overview

Position: Quality Control Training Specialist, Microbiology

Company: Iovance Biotherapeutics Inc.

Salary: Competitive

Company Overview:

Iovance Biotherapeutics is a dynamic, late-stage organization dedicated to the advancement and commercialization of innovative cancer immunotherapies. The Quality Control Training Specialist will play a crucial role in enhancing quality control training at our integrated Cell Therapy Center.

Role Summary:

The Quality Control Training Specialist, Microbiology will be responsible for facilitating quality control microbiology and environmental monitoring training. This includes in-process and final drug product microbial testing, focusing on critical areas such as bioburden, endotoxins, mycoplasma, gram stain, environmental monitoring, and sterility techniques. The position requires flexibility to work across various shifts, including weekends and holidays as necessary.

Key Responsibilities:

  • Serve as a subject matter expert (SME) to train new laboratory personnel.
  • Conduct training on environmental monitoring within cleanroom environments and growth promotion of microbiological media.
  • Lead classroom training sessions for Grade B gowning, including gowning qualifications and annual requalifications.
  • Instruct staff on gram stain, endotoxin, sterility testing, and mycoplasma testing methodologies.
  • Assist in troubleshooting and resolving issues related to GMP Quality Control.
  • Support the creation and revision of essential documentation, including SOPs, protocols, reports, deviations, laboratory investigations, CAPAs, and change controls.
  • Perform GMP Quality Control laboratory testing and environmental monitoring activities with a focus on accuracy and compliance with established procedures and regulations.
  • Conduct peer reviews of laboratory data and logbooks.
  • Contribute to functional laboratory and cross-functional team meetings.
  • Maintain a high level of efficiency, producing accurate and high-quality results.
  • Adhere to Iovance Biotherapeutics' core values, policies, and business ethics.
  • Comply with safety protocols and laboratory procedures as per company policy and OSHA regulations.
  • Perform additional duties as assigned.

Qualifications:

  • Bachelor's degree in a relevant field (biological sciences or equivalent).
  • A minimum of three (3) years of experience in the pharmaceutical industry within a Quality Control capacity.
  • Proven ability to develop training materials, conduct training sessions, and assess training program effectiveness.
  • Experience collaborating with multi-disciplinary teams.
  • Detail-oriented with strong technical skills.
  • Ability to manage multiple priorities effectively under tight deadlines.
  • Demonstrated ownership and accountability in work responsibilities.
  • Strong sense of urgency and ability to recognize time-sensitive tasks.
  • Familiarity with GDP, GLP, and GMP practices.
  • Excellent written and verbal communication skills for creating training documents and effectively guiding trainees.

Preferred Qualifications:

  • Advanced degree (MSc. preferred).
  • Experience with cell therapy products is advantageous.

Physical and Mental Demands:

This role requires the ability to meet the physical demands necessary to perform essential functions. Reasonable accommodations may be made upon request.

  • Ability to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE).
  • Must meet requirements for and be able to wear a half-face respirator.
  • Capable of standing and/or walking for 90% of the workday, which may include climbing ladders or steps.
  • Must possess near vision capabilities to view samples at close range.
  • Able to perform activities involving crouching, bending, twisting, reaching, and repetitive motions.
  • Must be able to lift and carry objects weighing up to 45 pounds.

Work Environment:

This position will involve working in both an office and a laboratory setting. In the lab, exposure to various chemical and biochemical agents may occur, including potential exposure to noise, equipment hazards, and strong odors. The role requires working in a cleanroom environment with biohazards and human blood components.

Iovance is committed to fostering a diverse and inclusive workplace. We are an equal-opportunity employer, and all employees and applicants will be considered without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other characteristic protected by applicable law.

  • Microbiology Quality Assurance Training Specialist

    2 weeks ago

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

    Iovance Biotherapeutics, Inc. is an innovative and expanding organization dedicated to the advancement and commercialization of groundbreaking cancer immunotherapies. The role of the Quality Control Training Specialist is pivotal in facilitating quality control training at our integrated Cell Therapy Center (iCTC). The Quality Control training initiatives...

  • Microbiology Quality Assurance Training Specialist

    2 weeks ago

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

    Iovance Biotherapeutics, Inc. is a dynamic and innovative organization dedicated to the advancement and commercialization of groundbreaking cancer immunotherapies. We are seeking a Quality Control Training Specialist to enhance our quality control training initiatives at our integrated Cell Therapy Center (iCTC). The Quality Control Training Specialist,...

  • Microbiology Quality Assurance Training Specialist

    2 weeks ago

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

    Iovance Biotherapeutics, Inc. is an innovative, late-stage organization dedicated to the advancement and commercialization of groundbreaking cancer immunotherapies. The role of the Quality Control Training Specialist is pivotal in facilitating quality control training at our integrated Cell Therapy Center (iCTC). The training programs in quality control...

  • Quality Control Training Specialist

    4 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Control Training Specialist to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for developing and delivering training programs for quality control personnel in the field of microbiology.Key ResponsibilitiesDevelop and implement training programs for quality control...

  • Quality Control Manager, Microbiology and Sample Management

    3 days ago

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

    Job SummaryWe are seeking a highly experienced Quality Control Manager, Microbiology and Sample Management to join our team at Iovance Biotherapeutics, Inc. This is a challenging and rewarding role that requires a strong background in microbiology, quality control, and leadership.Key ResponsibilitiesManage and oversee the day-to-day operations of the Quality...

  • Supervisor, Quality Assurance, Microbiology

    2 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryWe are seeking a highly skilled and experienced Supervisor, Quality Assurance, Microbiology to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for overseeing the routine operations and performing testing in the Quality Control Microbiology laboratory.Key ResponsibilitiesOversee Day-to-Day Operations:...

  • Quality Control Specialist II

    2 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryWe are seeking a highly skilled Quality Control Specialist II to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for supporting quality control testing operations at our Cell Therapy Center.Key ResponsibilitiesPerform daily cGMP quality control laboratory microbiological testing activities, including...

  • Microbiology Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewPosition Summary:The Quality Control Analyst will play a crucial role in ensuring the integrity of quality control testing processes at Iovance Biotherapeutics Inc. This position involves comprehensive microbial testing of both in-process and final drug products, focusing on critical assessments such as bioburden, endotoxin levels, gram staining,...

  • Quality Assurance Training Specialist

    7 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewSalary: CompetitiveCompany Overview:Iovance Biotherapeutics is a dynamic and innovative organization dedicated to the advancement and commercialization of groundbreaking cancer immunotherapies. We are seeking a Quality Control Training Specialist to enhance our quality control training initiatives at the integrated Cell Therapy Center (iCTC).Role...

  • Quality Control Analytical Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewPosition Title: Analytical Sciences & Technology Specialist ISalary: CompetitiveSummary:The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, including method and instrument validations, as well as technical transfers associated with Analytical and/or...

  • Quality Control Analytical Specialist

    7 days ago

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

    Position Overview The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, as well as the validation of methods and instruments. This role encompasses technical transfers associated with Analytical and/or Microbiological quality assurance testing of products, raw...

  • Quality Control Analytical Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewPosition Title: Analytical Sciences & Technology Specialist ISalary: CompetitiveRole Summary:The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, including the validation of methods and instruments, as well as the technical transfer related to Analytical...

  • Quality Control Analytical Specialist

    2 weeks ago

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

    Position Overview The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and procedures, including method and instrument validations, as well as technical transfers related to Analytical and/or Microbiological quality control assessments of products, raw materials, and packaging...

  • Quality Control Analytical Specialist

    7 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewPosition Title: Analytical Sciences & Technology Specialist ISalary: CompetitiveSummary:The Analytical Sciences & Technology Specialist I plays a pivotal role in the technical advancement of quality assurance methodologies and processes. This includes the validation of methods and instruments, as well as the technical transfer related to...

  • Quality Control Analytical Specialist

    7 days ago

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

    Position Overview The Analytical Sciences & Technology Specialist I is responsible for the technical advancement of quality assurance methodologies and processes, validation of methods and instruments, and technical transfers pertinent to Analytical and/or Microbiological quality assurance testing of products, raw materials, and packaging components. This...

  • Cell Therapy Quality Assurance Specialist

    4 days ago

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

    About the RoleWe are seeking a highly skilled Quality Control Training Specialist to join our team at Iovance Biotherapeutics, Inc. This is an exciting opportunity to work in a dynamic and growing company focused on the development and commercialization of novel cancer immunotherapies.Key ResponsibilitiesDevelop and deliver comprehensive training programs...

  • Quality Assurance Training Specialist, Analytics

    7 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewSalary:Company OverviewIovance Biotherapeutics is a dynamic and expanding organization dedicated to the advancement and commercialization of innovative cancer immunotherapies. The Quality Control Training Specialist will play a crucial role in facilitating quality control training at Iovance's integrated Cell Therapy Center (iCTC). The training...

  • Quality Assurance Training Specialist, Analytics

    7 days ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job OverviewSalary:Company OverviewIovance Biotherapeutics is a dynamic, late-stage organization dedicated to the advancement and commercialization of innovative cancer immunotherapies. The Quality Control Training Specialist plays a crucial role in facilitating quality control training at Iovance's integrated Cell Therapy Center (iCTC). The training...

  • Infection Control Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Temple University Full time

    Position OverviewThe Infection Control Specialist plays a critical role in safeguarding patient health by identifying and analyzing data related to hospital-acquired infections. This position is essential for developing strategies to mitigate risks associated with infection transmission.Key ResponsibilitiesCollect and evaluate relevant epidemiological data...

  • Senior Manager, Microbial Quality Control

    2 weeks ago

    Philadelphia, Pennsylvania, United States EPM Scientific Full time

    A leading biotech firm is expanding its microbiology division. This role will be pivotal in the formulation and management of the organization's microbial contamination control protocols, as well as facilitating new product transfers and conducting microbiological risk evaluations and trend analyses. As the Senior Manager of the Microbiology department, you...