Training Specialist

2 weeks ago

philadelphia, United States Planet Pharma Full time

Overview

We are seeking a Training Specialist I to join the Operations team. The 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 Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic gowning and qualification and ISO class 5 cleanroom operations is required.


Essential Functions and Responsibilities

  • Develops a basic understanding of the current cell therapy manufacturing process and the equipment utilized during processing, as this role is viewed as a subject matter expert (SME) within this specific area.
  • 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; Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • Presents and delivers content to manufacturing technicians.
  • Assists with the creation, review and improvement of designated training scripts; On the Job and Instructor Led Trainings (OJTs and ILTs).
  • Supports management with the alignment of manufacturing processes with technical training, ensuring consistency.
  • Helps to identify training needs; assists in establishing a feedback loop to ensure continuous improvement.
  • Assists with drafting SOPs, Batch Records, Deviations, CAPAs, etc. Performs revisions as needed to accurately reflect current procedures.
  • Appropriately escalates issues/concerns to Area Management for further investigation.
  • Works on assignments that are moderately complex in nature, where judgement is required to resolve or escalate operational issues without negatively impacting manufacturing efforts.
  • Troubleshoots unexpected results, prioritizes workload and solves moderately complex problems.
  • Possesses ability to work in a team environment or independently, as needed.
  • Must adhere to the Company's core values, policies, procedures and business ethics.
  • Complies with Safety SOPs, SDS sheets and laboratory procedures per company policy and OSHA regulations.
  • Performs miscellaneous duties as assigned.

Required Education, Skills, and Knowledge:

  • Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience
  • Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Technical knowledge of aseptic processing in cleanroom environments is a must.
  • Knowledge of and experience with in-lab skills training, including aseptic technique, cell culture processing, aseptic gowning and qualification is a must.
  • Experience leading “development” initiatives such as training, coaching/mentoring, learning initiatives.
  • Ability to mentor and provide best practices to new employees.
  • Ability to build relationships quickly and provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing environment, representing a variety of personalities and experience levels.
  • Ability to accurately and reproducibly perform arithmetic calculations including decimals, percentages and basic algebraic calculations.
  • Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
  • Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
  • Ability to work successfully in a fast-paced team-oriented setting.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Excellent presentation skills, both written and verbal.
  • Understands and complies with quality standards and requirements as documented.
  • Must have strong written and verbal communication and organizational skills.
  • Strong computer skills, problem solving and attention to detail.
  • Familiarity with data and sample management required (LIMS/MES).
  • Working knowledge within a Learning Management System (LMS).
  • Able to work independently with minimal supervision.
  • Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

Preferred Education, Skills and Knowledge:

  • Experience with cell and gene therapy.
  • Experience with Master Control.

Physical Demands and Activities Required:

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

  • Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, safety goggles, etc.
  • Must meet requirements for and be able to wear a half-face respirator.
  • Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors; may be given a visual exam for visual acuity and color perception.
  • Ability to stand and/or walk 90% (and sit 10%) within your scheduled workday.
  • Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing 25 pounds.

Mental:

  • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
  • Ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment:

  • This position will work in both an office environment and a manufacturing lab setting.
  • Must be able to work in laboratory setting with various chemical/biochemical exposures, including latex and bleach.
  • Able to work in cleanroom with biohazards, human blood components, and chemicals.
  • Potential exposure to noise and equipment hazards and strong odors.
  • Must be able to work in environment with variable noise levels.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

  • Training Specialist

    1 week ago

    Philadelphia, United States pureIntegration Full time

    We are seeking a motivated Training Specialist to join our Change Management team. Reporting to the Director of Change Management, you will be responsible for designing and delivering key training initiatives that support our change management strategy. This includes conducting training needs assessments, creating engaging curricula and learning materials,...

  • Training Specialist

    1 month ago

    Philadelphia, United States Continental Tide Full time

    Training SpecialistCompany Overview:Continental Tide Defense Systems, Inc. (Continental Tide) is an industry leader, providing engineering and industrial services to the U.S. Navy, U.S. Coast Guard, Military Sealift Command, and other DoD organizations. At Continental Tide, we understand that a great company culture is one where employees know their voice is...

  • Training Specialist

    3 weeks ago

    Philadelphia, United States Planet Pharma Full time

    OverviewWe are seeking a Training Specialist I to join the Operations team. The 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...

  • Training Specialist

    3 weeks ago

    philadelphia, United States Planet Pharma Full time

    OverviewWe are seeking a Training Specialist I to join the Operations team. The 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...

  • Training Specialist

    2 months ago

    Philadelphia, United States Planet Pharma Full time

    614407 Training Specialist IDirect HirePhiladelphia, PAMonday to Friday, first shift The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic gowning and qualification and ISO class 5 cleanroom operations is required. Essential Functions and Responsibilities...

  • Training Specialist

    2 months ago

    Philadelphia, United States Planet Pharma Full time

    614407 Training Specialist IDirect HirePhiladelphia, PAMonday to Friday, first shift The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic gowning and qualification and ISO class 5 cleanroom operations is required. Essential Functions and Responsibilities...

  • Training Specialist Supervisor

    4 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job DescriptionIovance Biotherapeutics Inc is seeking a highly skilled Training Specialist Supervisor to join our team at the Iovance Cell Therapy Center (iCTC). As a key member of our Manufacturing Training Department, you will play a pivotal role in overseeing and executing training programs for our aseptic manufacturing team.Key Responsibilities:Oversee...

  • Training Specialist I

    2 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryIovance Biotherapeutics Inc is seeking a highly skilled Training Specialist I to join our Operations team. The successful candidate will be responsible for developing and delivering training programs for our cell therapy manufacturing team.Key ResponsibilitiesDevelop and deliver training programs for manufacturing techniciansAssist with the...

  • Training Specialist I

    1 week ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Description:The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic gowning and qualification and ISO class 5 cleanroom operations is required.Develops a basic understanding of the current cell therapy manufacturing process and the equipment utilized...

  • Training Specialist

    3 weeks ago

    Philadelphia, United States Eminence Organic Skin Care Full time

    Training Specialist – Eastern Pennsylvania (Philadelphia and surrounding cities)Full-Time Remote/Telecommute positionContracted & commission-based roleEsthetics License RequiredRole SummaryThe Training Specialist will contract directly to the Outside Sales Representative (OSR) to represent Eminence and is not an employee of Eminence. The roles and...

  • Training Specialist

    1 month ago

    Philadelphia, United States Eminence Organic Skin Care Full time

    Training Specialist – Eastern Pennsylvania (Philadelphia and surrounding cities)Full-Time Remote/Telecommute positionContracted & commission-based roleEsthetics License RequiredRole SummaryThe Training Specialist will contract directly to the Outside Sales Representative (OSR) to represent Eminence and is not an employee of Eminence. The roles and...

  • Training Specialist

    3 weeks ago

    philadelphia, United States Eminence Organic Skin Care Full time

    Training Specialist – Eastern Pennsylvania (Philadelphia and surrounding cities)Full-Time Remote/Telecommute positionContracted & commission-based roleEsthetics License RequiredRole SummaryThe Training Specialist will contract directly to the Outside Sales Representative (OSR) to represent Eminence and is not an employee of Eminence. The roles and...

  • Quality Control Training Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job SummaryIovance Biotherapeutics Inc is seeking a highly skilled Quality Control Training Specialist to support quality control training at our integrated Cell Therapy Center (iCTC). The successful candidate will have hands-on laboratory training experience in cell culture, cell-based potency assays, and multicolor flow cytometry platforms.The Quality...

  • Training and User Support Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States NavitsPartners Full time

    Job OverviewNavitsPartners is seeking a skilled Training and User Support Specialist to develop and implement training programs for external stakeholders.The ideal candidate will have excellent communication and public speaking skills, as well as proficiency in Microsoft Office Suite.Key Responsibilities:Design and deliver training programs for users.Present...

  • Clinical Educator

    3 weeks ago

    Philadelphia, Pennsylvania, United States Destinationone Consulting Full time

    Clinical Educator - Radiology Training SpecialistDestinationone Consulting is seeking a Clinical Educator - Radiology Training Specialist to provide training and education to radiology staff and students. The ideal candidate will have a strong background in radiology and teaching, with excellent communication and presentation skills.Key...

  • Training Consultant

    1 week ago

    Philadelphia, Pennsylvania, United States Eminence Organic Skin Care Full time

    Job Title: Training SpecialistJob Summary:Eminence Organic Skin Care seeks a skilled Training Specialist to join our team. In this role, you will provide exceptional training and sales support to our Spa Partners, working closely with our Outside Sales Representatives and Central Office team in Vancouver, Canada.Key Responsibilities:Conduct regular business...

  • Quality Control Training Specialist

    3 weeks ago

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

    Job SummaryWe are seeking a highly skilled Quality Control Training Specialist to support quality control training at our integrated Cell Therapy Center (iCTC). The successful candidate will have hands-on laboratory training experience in cell culture, cell count determination, and cell-based potency assays.Key Responsibilities:Train new laboratory personnel...

  • Training Specialist I

    3 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Description:The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic gowning and qualification and ISO class 5 cleanroom operations is required.Key Responsibilities:Develops a basic understanding of the current cell therapy manufacturing process and the...

  • Training Specialist I

    2 months ago

    philadelphia, United States Planet Pharma Full time

    Monday to Friday, first shiftSalary $80-82k, 10% bonus, and long-term incentives *MUST have a background in pharma/GMP, and need to have experience training people in some capacity**Job Description:The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic...

  • Training Specialist I

    2 months ago

    Philadelphia, United States Planet Pharma Full time

    Monday to Friday, first shiftSalary $80-82k, 10% bonus, and long-term incentives *MUST have a background in pharma/GMP, and need to have experience training people in some capacity**Job Description:The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic...