About The Role:
As a Technical Training Manager within the Quality Management Training team, you’ll play a lead role in training and developing associates on GMP-regulated processes that support our AAV Manufacturing operations. Reporting to the Director, GMP Quality Training, you’ll own the delivery of training through hands-on and classroom instruction, actively observe performance, and mentor associates to ensure they are trained, qualified, and confident in their work. You’ll lead qualification and requalification activities, document results in compliance with GDP, and maintain your own process and gowning qualifications to serve as a subject matter expert. While this position is primarily focused on training delivery and mentoring, you’ll also shape the program by identifying training gaps, sharing feedback with supervisors, and recommending improvements to strengthen training methods, content, and overall effectiveness.
Responsibilities:
Training Delivery and Qualification:
- Serve as a subject matter expert and technical lead for GMP Manufacturing operations, owning the delivery of training through classroom instruction, one-on-one coaching, and hands-on, on-the-job practice.
- Mentor associates throughout their development, actively observe and evaluate performance, and ensure their successful transition to independent work.
- Coordinate and lead qualification and requalification activities by assessing proficiency, verifying proper execution of GMP-regulated processes, and ensuring all results are accurately documented in compliance with GDP.
Training Coordination and Compliance:
- Take ownership of Manufacturing training program compliance by providing clear, actionable feedback to associates and management on training progress, performance observations, and identified gaps.
- Be accountable for upholding GMP/GDP expectations through accurate qualification documentation and consistent reinforcement of training standards.
- Be cross-trained in the Training Management System (e.g., Veeva Vault) to provide oversight and ensure accuracy in recordkeeping, compliance tracking, and reporting when required.
Program Development and Content Management:
- Take ownership of developing and maintaining training programs that directly support Manufacturing, working in close partnership with Manufacturing leadership and the Training team.
- Lead the design of area-specific training content, on-the-job training initiatives, and qualification processes to ensure associates are fully prepared for independent work.
- Own the revisions, updates, and periodic reviews of training materials, ensuring they remain current with SOPs, process changes, and continuous improvement activities.
Continuous Improvement and Support:
- Take ownership of continuous improvement within training programs by monitoring effectiveness, proactively communicating findings to leadership, and driving remediation or enhancements where needed.
- Identify training gaps, recommend improvements, and implement stronger training methods to elevate associate performance and compliance.
- Maintain gowning and manufacturing process qualifications to serve as a subject matter expert and technical lead during training activities, ensuring associates are consistently prepared for independent work.
Qualifications:
- Associate’s degree in Life Sciences, Biotechnology, or a related technical field required; Bachelor’s degree strongly preferred. Equivalent experience may be considered.
- 3-5 years of experience in GMP-regulated manufacturing (biotech, pharmaceutical, or medical device), with advanced knowledge of AAV bioprocess manufacturing and aseptic techniques/practices.
- Demonstrated experience leading training activities, mentoring associates, and serving as a recognized Subject Matter Expert within Manufacturing operations.
- Proven ability to deliver hands-on, on-the-job training and conduct qualification assessments in compliance with GMP/GDP requirements.
- Advanced communication and facilitation skills, with the ability to simplify complex technical concepts and engage diverse audiences.
- Experience working cross-functionally with Manufacturing, Quality, Process Development, and Training teams to align training with both business objectives and compliance requirements.
- Strong organizational and leadership skills, with the ability to manage multiple training priorities and influence program outcomes.
- Knowledge of adult learning principles and training design methodologies (e.g., ADDIE).
- Ability to work onsite in Columbus, Ohio 3-4 days/week on average.
- Ability to work in a cleanroom environment, that requires wearing full Personal Protective Equipment (PPE), including gowns, gloves, masks, and safety glasses.
Preferred Skills:
- Demonstrated success in leading training initiatives, mentoring associates, and serving as a recognized SME within GMP-regulated environments.
- Expertise in AAV bioprocess manufacturing, including cell culture operations, aseptic techniques, and cleanroom behaviors.
- Proficiency with electronic training systems such as Veeva Vault or similar platforms, with the ability to interpret and leverage training data.
- Proven ability to identify training gaps, recommend improvements, and implement enhancements that strengthen program effectiveness.
_This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned._
