The Training Associate II will have the responsibility for performing a variety of tasks related to learning and development in a Good Manufacturing Practices (GMPs) facility. The position requires providing classroom and laboratory training to site employees who produce and/or support Master and Working Cell Banks. The ideal candidate will have strong communication and leadership skills. The individual must be able to coach and mentor trainees and elevate issues to proper personnel timely.

Schedule for this role:  Monday - Friday 8:00am - 5:00pm (core business hours)

Overview:

• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations.
• Able to coach and mentor others to do the same.
• Follows, executes and trains others to follow and execute Standard Operating Procedures (SOPs) and Batch Records (BRs).
• Performs, trains, coaches and mentors others to maintain record filed and databases.
• Possess basic computer skills and able to efficiently use basic Microsoft applications.
• Suggests, participates, implements and leads continuous improvement ideas.
• Assigns training work assignments.
• May participate, supports, presents and represents as a SME during regulatory inspections and client audits.
• Performs well under minimal supervision and works independently on training tasks and processes.
• Contributes to the overall operations and to the achievement of departmental goals.
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and Advanced Therapies Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.

• Trains, coaches and mentors others on basic aseptic operational techniques such as gowning, media preparation, thaw, passage and harvesting and overall systems and operations.
• Ensure safety, compliance and adherence to standard operating procedures (SOPs) that ultimately provide GMPs and on time delivery to the customer.
• Provide trainees with constructive feedback & coaching.
• Delivers instructor led training (ILT) presentations pertaining to GxP activities.
• Conducts mock or simulation sessions as means for delivering training.
• Understands and trains others on basic operations and functions of equipment and is able to perform basic troubleshooting.
• Performs and delivers aseptic technique concepts while incorporating clean room behaviors.
• Understands and is able to explain ‘why’ of acceptable and unacceptable aseptic technique practices.
• Perform training in the laboratory setting.
• Design departmental training for the site.
• May assist with developing and delivering alternative and unique training approaches.
• Experience with providing coaching to others, supporting them in identifying their development areas and navigating solutions.
• Assist management with developing training assessments geared towards the adult learner to assess training effectiveness.
• May train others on the performance of solution and material preparation.

• High School diploma and over 6 years of relevant experience or
• Associates’/Bachelor’s (science preferred) degree with over 3 years of relevant or equivalent experience
• Ideally has knowledge of curriculum design
• Ideally possesses learning and/or training accreditations and certifications
• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, ideally in cell and gene therapy
• Understands the concept of and has performed or experience with manufacturing processes and methods
• Has knowledge and experience with Good Documentation Practices(GDP).