Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The Opportunity
We are seeking a highly motivated Senior Manufacturing Learning Specialist to build capability and compliance for REGENXBIO's 1st internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing facility. As a member of the highly engaged and collaborative Manufacturing Operations team, you will have the unique opportunity to develop and deploy learning and operational excellence initiatives at a start-up, multi-product, single-use facility. You will play an important role inleading the establishment of learning and operational excellence programs to enable the manufacturing operations team to execute their roles successful and produce quality products for our patients.
What You'll Be Doing
- Embody our core values working collaboratively, building strong relationships and using clear communication to meet shared objectives.
- Create, implement, coordinate, and facilitate instructor led and on-the-job training on a variety of topics (e.g. New Employee Induction, Train the Trainer, computer system software, GMP equipment and processes, business process).
- Develop training in a variety of modalities including Instructor-led, On-the-Job, virtual.
- Perform administration of the Learning Management Systems (LMS) including item/ curricula creation, assignment, reporting, and more.
- Develop and foster a continuous improvement culture through leading training, projects, and initiatives related to 6S, performance management, problem solving, and standard work.
- Perform root cause analysis investigations for deviations and determine appropriate CAPAs with input from stakeholders.
- Lead large cross-functional projects and project teams.
- Partner with functional stakeholders on broad scope learning and development needs and human performance improvements.
- Participate in internal and external audits.
- Work quickly and effectively in Word, Excel, PowerPoint, SmartSheet, and Veeva systems.
- Review, edit, and author SOPs, Work Instructions, Job Aids, Training Plans, Batch Records and other documentation as required.
We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
- Minimum of 8 cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish, with a minimum of 2 years in a Training or Operational Excellence function.
- Strong experience in cGMP quality systems, knowledge of cGMP regulations.
- Excellent interpersonal, oral, and written communication skills.
- Excellent teaching and facilitation skills for on-the-job training and classroom-based training.
- Proficient in training creation and implementation, for a variety of training modalities (ILC, OJT, eLearning).
- Ability to apply continuous improvement and operational excellence strategies within a manufacturing organization.
- Experience performing LMS administration.
- Experience planning and managing complex projects through cross-functional teamwork.
- Experience in technical writing and authoring Batch Records, Standard Operating Procedures, Work Instructions, Training Plans or similar.
- Experience in end-to-end deviation management; from facilitating effective root cause analysis meetings to writing final deviation summary reports.
- Ability to manage change; able to lead business changes and implement new programs.
- Ability to work collaboratively with colleagues in a results-driven, team-oriented environment.
- Strong organization skills.
- Self-motivated, resourceful, flexible, and dynamic.
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally. Apply for this job
