BioProcess Engineer- Bioreactor, Cell Expansion (Manufacturing Associate)

Location
Libertyville, IL, US
Posted
Dec 21, 2020
Ref
3988
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? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

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 BioProcess Engineer is responsible organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment.

Responsibilities
  • Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
  • Support the product requirements to ensure that all products are produced according to plan.
  • Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed.
  • Participate in information requests for FDA and internal audits of the manufacturing facilities.
  • Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process.
  • Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
  • Look for opportunities to implement operational excellence and continuous improvement.
  • Partner with Quality to ensure a quality and compliant manufacturing environment.
  • Assist the technical operations team to resolve any issues related to production.

Qualifications
  • 2-4 years' experience in Biological Manufacturing environment.
  • Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
  • Excellent oral and written communication skills.
  • Preferred: 2-4 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems, strong technical writing ability and proven ability to effectively lead and participate on teams.
  • Ability to work a 12 hour rotating shift including evenings and/or weekends.

The level of this position will be based on the final candidate's qualifications.

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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