Operations Process Trainer, Aseptic Process
$75k/y-$99k/y
BioSpace3 months ago
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OnsiteFull-timeMid
Summary
Legend Biotech is seeking an Operations Process Trainer, Aseptic Process to join their Technical Operations team in Raritan, NJ. The role involves performing process training activities for Operations team members supporting cGMP Clinical and Commercial Cell Therapy Manufacturing.
About the Role
As an Operations Process Trainer, you will lead and deliver a comprehensive process qualification program for Operations trainees, manage and coordinate hands-on training curriculum, conduct assessments of new trainees, and collaborate with Operations Management to enhance training processes and compliance. You will also support daily manufacturing activities and maintain training metrics.
About You
Required:
- Bachelor's Degree in a Life Sciences field or equivalent technical discipline/experience.
- Minimum of 4 years relevant work experience in an aseptic manufacturing facility.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products.
- Experience with training methodology, adult learning theory, and instructional design.
Preferred:
- Curriculum and module design experience.
- Advanced computer skills and practical knowledge of MS Office Suite and SharePoint.
- Strong analytical, problem-solving, and critical thinking skills.
Benefits
- Medical, dental, and vision insurance.
- 401(k) retirement plan with company match that vests fully on day one.
- Equity and stock options for eligible roles.
- Eight weeks of paid parental leave after three months of employment.
- Paid time off policy including 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays.
- Flexible spending and health savings accounts.
- Life and AD&D insurance, short- and long-term disability coverage.
- Legal assistance and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
- Commuter benefits and family planning resources.
BioSpace
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Raritan, NJ