Cell Therapy Training Specialist

R&D Partners; Pennsylvania; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a dynamic Cell Therapy Training Specialist to enhance their autologous cell therapy manufacturing program. This role is pivotal in developing training content and delivering essential training to manufacturing technicians, ensuring adherence to Good Manufacturing Practices and regulatory standards. The ideal candidate will possess a strong background in cell culture and aseptic techniques, along with leadership skills to foster a culture of continuous improvement. Join a forward-thinking organization that values innovation and quality in a complex manufacturing environment, where your contributions will directly impact the success of cutting-edge therapies.

Qualifications

• Bachelor's degree in a related field and 2 years of GMP manufacturing experience required.
• Technical knowledge of aseptic processing in cleanroom environments is essential.

Responsibilities

• Develop training content and deliver training to manufacturing technicians.
• Ensure compliance with GMP, SOPs, and regulatory requirements.

Skills

Cell Culture

Aseptic Technique

Aseptic Gowning

ISO Class 5 Cleanroom Operations

Good Manufacturing Practices (GMP)

Training Development

Quality Mindset

Data Management (LIMS/MES)

Learning Management System (LMS)

Leadership Skills

Education

Bachelor’s Degree in Biology

Bachelor’s Degree in Biochemistry

Bachelor’s Degree in Bioengineering

Tools

Learning Management System (LMS)

Data Management Systems (LIMS/MES)

Job description

R&D Partners

Cell Therapy Training Specialist

Philadelphia Metro Area, PA, US

Job Type: Scientific

Job Number: JN-092024-32773

Region: Philadelphia Metro Area

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.

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.
• Complies with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

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.
• 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.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Familiarity with data and sample management required (LIMS/MES).
• Working knowledge within a Learning Management System (LMS).

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