Learning and Development Specialist II

• Manage the LMS/LxP, including curricula management, scheduling, tracking, and reporting training progress.
• Ensure management of training records and compliance with Regulatory Agency expectations for GxP Training and Corporate expectations for mandatory non-GxP training assignments.
• Provide LMS reports for KPI monitoring, regulatory audits, and inspections.
• Maintain training mailbox and Service Now tool for troubleshooting & site support.
• Support LMS/LxP and training material continuous improvement and escalate issues.
• Prepare and process learner assignment modifications.
• Create, publish, and assign training courses.
• Help deploy the site learning roadmap to deliver on skills & capability building for future-ready capability.
• Bloom content curation.
• Deliver classroom, on-the-job, and virtual training sessions as required.
• Facilitate training programs for new hires and existing colleagues.
• Lead curricula management activities for managing GxP & non-GxP Training curricula.
• Collaborate with managers to identify learning needs for the site learning roadmap anticipating future ready skills.
• Instructional Design – work with area SMEs to develop training materials, (e.g. presentations, job aids, SOPs, e-learning courses, and assessments).Manage these materials in Veeva & LMS for curricula assignment.
• Ensure training content complies with industry standards and regulatory requirements (e.g. GMP, EHS, Corporate expectations)
• Track training KPIs, (e.g. Gxp and non-GxP training KPIs and 3 hours learning per employee per month).
• Provide regular updates to the Site Learning Lead and site leadership on KPIs.
• Participate in audits regarding training compliance with regulatory standards/expectations and corporate expectations (GIA)

• BS/BA degree in Life Science or equivalent relevant experience. Experience of managing training in a GxP environment a must.
• Minimum of 5+ years of experience in LMS Administration, training, knowledge management and instructional design. Database skills required.
• 2+ years of experience in a Training, Learning and Development, or Manufacturing Operations role within a regulated manufacturing environment (e.g., pharmaceuticals, biotechnology, food & beverage).
• Experience delivering on-the-job training, classroom training, and using e-learning software.
• Proficiency with Learning Management Systems (LMS) - SuccessFactors, and MS Office Suite (Excel, PowerPoint, Word) and other training tools (e.g., Articulate, Captivate).
• Facilitation, with the ability to engage and motivate employees in learning sessions.

• Experience in deployment of LMS in global biotech / pharmaceutical manufacturing
• Knowledge of adult learning principles and training methodologies, including Blended Learning, Instructional Design, and Learning Technologies.
• Knowledge of regulatory compliance and safety standards in manufacturing, including cGMP, OSHA, and environmental regulations.

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

Takeda