Internship, Site Quality Operations

Location
Durham, NC, US
Posted
Sep 14, 2020
Ref
5532
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 Summer Intern will work at the Novartis Gene Therapy, Durham NC site on various activities included, but not limited to, QA operations (focus on manufacturing and engineering), quality systems/compliance and/or quality control.

Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Complete requisite training as well as all applicable policies and procedures related to the specific job function. The successful candidate will take accountability to ensure all documentation is complete and accurate, so issues can be addressed real time.

Responsibilities
  • Execution of projects to streamline QA operations activities that may include batch and material review/disposition, review of protocols for qualification activities, deviation response, executing time studies to support resource modeling and scheduling.
  • Partnering with cross-functional teams on projects to improve Right First Time, support process improvement, and implementation of operational excellence tools.
  • Provides cGMP observations to management; presents information to employees and management.
  • Ensure cGMP documentation is being filled out correctly, training is current, and all Quality requirements are being followed.

Qualifications
  • Enrolled in a 4 year program, pursuing a bachelor's degree in biochemistry, chemical engineering, bioengineering, or science related field.
  • Excellent oral and written communication skills.
  • 3.0 GPA.


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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