GMP Quality Trainer

Company: Molecular Templates, Inc.
Location: Austin
Posted on: February 15, 2020

Job Description:

Company Description:Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM currently has several ETB candidates in clinical development including MT-3724 and MT-5111. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development. For more information, please visit MTEM's website at . Position Overview:Molecular Templates is seeking a highly skilled and motivated learning and development professional in our Quality Assurance department to maximize GMP and GDP Compliance used in manufacturing and testing operations. The GMP Trainer will be responsible for creating GMP, GDP, and compliance training materials, conducting and monitoring training activities with the objective of enabling Right-First-Time execution. The GMP Trainer will leverage the learning sciences and create a learning and development progression where team members are set-up for success, working through training on a wide array of GMP and compliance issues supporting the regulated environment of MTEM. This position will help develop and maintain the lifecycle of the training program and work cross functionally to develop procedures and documentation used in quality and compliance functions. Through the training program, this role will positively influence human behavior in execution to accomplish desired outcomes. Job Responsibilities will include:

• Develop and deliver training sessions to new and current team members
• Maintain and monitor essential training for work in a GMP environment
• Monitor training compliance and critical process training coverage
• Determine training needs and establish training curriculum for GMP and compliance
• Coordinate with internal and external subject matter experts to deliver needed content
• Develop performance-based assessments quality and compliance systems
• Maintain and monitor training documentation, records and systems
• Monitor human performance and support continuous improvement efforts thereof
• Develop and improve human performance related key measures
• Liaise with team leads and supervisor to support and mentor new employees
• Collaborative with cross-functional teams and trainers to develop and deliver training
• Maintain the lifecycle of the training program
• Support weekend/night work to cover training needs
• Ensure that MTEM is fully compliant the regulatory and industry expectations concerning training. Qualifications/Skills:
  • Bachelor's degree in Life Sciences or equivalent applicable experience GMP Manufacturing environment, required. Learning or Behavioral Science background preferred.
  • 5 or more years of related professional experience developing and delivering training materials in a regulated environment, required.
  • Experience with lean manufacturing and continuous improvement principles, required.
  • Experience in biopharmaceutical industry and purification of proteins, preferred.
  • Excellent communication skills, written and verbal.
  • Excellent computer skills with knowledge of spreadsheet and word processing.
  • Demonstrated ability to breakdown quality and compliance processes, teach relevant content and assess demonstrated personnel competency.
  • Ability to evaluate and assess trends, problem solve, and integrate mistake proofing tools and techniques into process procedures and operations.
  • Ability to manage multiple projects and competing priorities.
  • Initiative and ability to function independently.
  • Maintain positive, productive relationships with functional and cross functional team members.
  • Flexible, resourceful and comfortable working in a fast-paced, dynamic team environment. Reporting Structure:This position has no supervisory responsibilities. This position reports to the Manager, Quality Systems.Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.Molecular Templates Inc

Keywords: Molecular Templates, Inc., Austin , GMP Quality Trainer, Human Resources , Austin, Texas