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
REGENXBIO is currently looking for a highly motivated individual to join our Manufacturing Operations team! As a contract-member of the highly engaged and collaborative group, you will have the unique opportunity to start-up an agile, multi-product, single-use facility. You will be accountable for supporting the establishment of new processes, procedures and ways of working, as well as performing manufacturing process related tasks and unit operations within the Upstream and Downstream areas.
What You'll Be Doing
- Opportunity to work in an “ALL” stream environment that allows for cross-functional development between the differing manufacturing areas, i.e. media/buffer prep, upstream (US), and downstream (DS).
- Support and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment.
- Partner with Quality to maintain a robust quality and compliance culture and performance that meets applicable GMP regulatory standards and supports regulatory inspections.
- Execute and support operational readiness activities for the NEW internal manufacturing facility, including the establishment of manufacturing procedures and standard practices, facility start-up, commissioning, and qualification of equipment and automation.
- Review, revise and/or author a growing library of GMP documentation.
- Proactively work to achieve training competency in an expanding manufacturing facility.
- Perform as a qualified trainer for assigned GMP manufacturing operations, processes and equipment for US and DS areas.
- Support root cause analysis for Manufacturing events and assist with investigations.
- Lead projects of minor to moderate scope with the support of cross-functional stakeholders.
- Lead continuous improvement projects within functional area.
Experience & Qualifications
- Bachelor’s degree OR Associate’s degree/High School Diploma with relevant cGMP experience.
- Prior cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish.
- Associate level requirement: 0-2 years’ experience
- Specialist level requirement: 2-4 years’ experience
- Moderate to strong oral and written communication skills.
- Moderate to strong teaching and facilitation skills for on-the-job training delivery.
- Proficient reviewing and/or revising GMP documentation (i.e. SOPs, Batch Records, etc.).
- Ability to apply continuous improvement strategies within a manufacturing organization.
- Experience with GMP quality systems, including support of deviation root cause analysis.
- Knowledge of manufacturing processes and equipment to facilitate identification and escalation of problems to the appropriate support group.
- Ability to work collaboratively with colleagues in a results-driven, team-oriented environment.
$29 - $35 an hourApply for this job
