Engineer, Manufacturing Science and Technology (Drug Product)

Location
Libertyville, IL, US
Posted
Sep 02, 2020
Ref
5387
Hotbed
BioMidwest
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.

With cutting-edge technology, we are making progress in the treatment of rare and life-threatening neurological genetic diseases. Our initial gene therapy for spinal muscular atrophy (SMA) has been approved in the U.S., Japan, EU and Brazil.

The Engineer, Manufacturing Science and Technology assists with the development and improvement activities for the drug product manufacturing processes used to manufacture Novartis Gene Therapies products at a site. This role supports the collection and interpretation of continued process verification data and collaborates with other departments on manufacturing related issues to drive resolution and process improvements.

Responsibilities
  • Serves as a scientific and technical representative for drug product process-related issues and investigations at the facility.
  • Performs trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • Supports tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
  • Looks for opportunities to implement operational excellence and continuous improvement.
  • Partners with Quality to ensure a compliant manufacturing environment.
  • Assist the technical operations team to resolve any issues related to production.
  • Partners with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
  • Implements potential process improvements in conjunction with operations.
  • Participates in start-up efforts of new equipment, software or processes in manufacturing.
  • Assists in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
  • Provides technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports.
  • Utilizes small-scale production processes and scaled-down lab processes to enable process troubleshooting.
  • Completes requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.
  • May work on special projects related to development and improvement of business and/or manufacturing processes.
  • Other related duties as assigned.

Qualifications
  • Bachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field.
  • 2 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in aseptic fill/finish.
  • Excellent oral and written communication skills.
  • Additional experience in cell culture, recovery, or purification is also beneficial.
  • Familiar with global regulations on devices, drugs, validation/qualification requirements.
  • Strong technical writing ability.
  • Proven ability to effectively participate on teams.
  • Up to 25% travel.


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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