Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Collaborates with team to ensure business objectives are met through effective learning solutions; administers, oversees and organizes job specific training programs for IOPS (Industrial Operations & Product Supply). This position is a vital member of IOPS Technical Training Team that is passionate about training & committed to excellence while ensuring IOPS employees are not only trained, but trained well.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Provides leadership and ensures continuous improvement to the Quality Training System and the GMP Program according to GMP and current industry standards.
* Executes GMP training program for new and existing employees.
* Responsible for group and individual GMP training sessions (e.g. scheduling, assignments).
* Provides guidance to supported business partners ensuring compliance in GMP training practices and documentation.
* Interfaces with all good manufacturing practices groups to provide support and oversight of training compliance.
* Participates in other quality systems activities such as internal audit, inspection preparation and change control as required.
* In collaboration with subject matter expert(s) and Learning Design Specialist, may develop training materials for use in training courses, with high attention to quality, role-specificity, and engaging learning experience. (e.g. training workbooks, training manuals, and computer based training).
* Delivers dynamic and interactive GMP classroom training. (e.g. New Employee GMP training, Annual GMP Refresher, Train the Trainer).
* Leverages knowledge of business and customers in order to identify SMEs and potential departmental trainers.
* Consults with Learning Management System Administrator to report ongoing issues that impact quality, compliance, and effectiveness for the organization.
* Conducts Learning Needs Analysis and Gap Assessments.
* Maintain, update and coordinate role based curriculum or training matrices.
* Supports IOPS Technical Training and organizational training initiatives.
* Manages and support the development of OJT Task Evaluations, work instructions, OJT content standards, and job aids according to IOPS guidelines.
* Tracks, trends and monitors training compliance; prepares routine progress reports on job specific training programs for management.
* Focuses on continuous improvement on training materials, programs and processes.
Knowledge and Skills:
Education and Experience:
* Tenacity to drive projects to completion in a highly ambiguous work environment
* Superior organizational skills
* Ability to prioritize and manage multiple tasks in a process oriented environment
* Excellent written and oral communication skills
* Requires BS/BA in related field and 3+ years of relevant experience. Related experience may be substituted in lieu of education.
* Experience in a GMP or other regulated environment strongly preferred.
* Ideal candidate should have experience with content development, leading adult learning, needs assessments, measuring training effectiveness, and delivering presentations.
Title level (Associate Specialist, Specialist, or Senior Specialist) will be determined based on skills and experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.