Training Specialist

We're Hiring: Training Specialist! We are seeking a dynamic and experienced Training Specialist to design, develop, and deliver comprehensive training programs that enhance employee skills and drive organizational success. The ideal candidate will have a passion for learning and development, strong facilitation skills, and the ability to create engaging training content that meets diverse learning needs.

Location: Philadelphia, PA

Work Mode: Work From Office

Role: Training Specialist

Position Summary: 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 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 judgment 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 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 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, and 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 a manufacturing environment
• Ability to accurately and reproducibly perform arithmetic calculations, including decimals, percentages, and basic algebraic calculations
• Proactive, results-oriented self-starter with strong leadership skills and experience in a complex manufacturing environment
• Ability to deal with ambiguity—ready to change gears quickly and 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
• Strong written, verbal communication, and organizational skills
• Strong computer skills, problem-solving abilities, and attention to detail
• Familiarity with data and sample management systems (LIMS/MES)
• Working knowledge of Learning Management Systems (LMS)
• Able to work independently with minimal supervision
• Must be able to read, write, and understand English
• Proficiency in Microsoft Office (Excel, Word, Outlook)
  
  

Preferred Education, Skills, and Knowledge:

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