Senior Specialist, Manufacturing Learning and Performance

Location
Durham, NC, US
Posted
Oct 02, 2020
Ref
5624
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Senior Specialist, Manufacturing Learning and Performance is responsible for supporting the manufacturing team in completion of department training objectives and goals. This role encompasses a broad range of aspects to leverage training as a strategic advantage.

Responsibilities
  • On-boarding new employees following site-led high-level new employee orientation.
  • Develops, delivers, and maintains intensive manufacturing training on-boarding program.
  • Standardize and optimize the timeline from employee new hire to qualified GMP manufacturing capability
  • Develops and implements training partnerships with external resources.
  • Improves, standardize and partners with the other manufacturing site stakeholders to globalize on-the-job training qualification documents.
  • Training delivery including application of adult learning principals, classroom delivery, and on-the-job training for introductory concepts.
  • Delivers training on introductory concepts and skills.
  • Collaborates with organizational leaders in the planning, scheduling, and completion of OJTs for a large team of staff.
  • Supports the Learning Management Quality System and partner with site training function to ensure alignment.
  • Maintains curriculum architecture and modify for new processes and products as needed.
  • Routes LMS forms and workflows in support of the quality system.
  • Establish, run, report and trend training completion metrics for the organization.
  • Develops other training materials using sound instructional design practices.
  • Brings Human Performance thinking to the site and department.
  • Other related duties as assigned.

Qualifications
  • Bachelor's degree in Science or training related area and 7 years of experience in training within a GMP, regulatory/pharmaceutical environment or 11 years equivalent education and training combination.
  • Experience with Learning Management Systems including curriculum architecture and design, role-task-based modular learning, routing of GMP forms and workflows, and metrics tracking and reporting.
  • Experience in instructional design including actionable learning objectives, ADDIE model application, training effectiveness evaluation, and OJT templates and writing.
  • Highly skilled in MS Word, Excel, PowerPoint and other eLearning software.
  • Solid organizational, time and project management skills.
  • Ability to operate in a highly detailed manner.
  • Proven facilitation and presentation skills.
  • Ability to work precisely according to procedures, rules and regulations and have a passion for continuous improvement and quality.
  • Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.
  • Experience in Human performance and/or certification a plus.


The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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