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BioProcess Engineer I

Employer
Novartis Gene Therapies
Location
Durham, NC
Start date
Jul 21, 2022
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Imagine… 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.


The BioProcess Engineer I is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the plant/site.

 

Please note: Multiple positions are available and will have cell expansion, upstream or downstream focus. These roles work a rotating 2-2-3 schedule. 12 hour shift. Shift hours are either days - 6:00am to 6:00pm or nights - 6:00pm to 6:00am. Please indicate your shift preference when applying. 

Responsibilities

  • Assists in manufacturing led investigations through partnerships with Quality and other business units at the site.
  • Produces product, media/buffer preparation, learn to troubleshoot equipment, participate in interviews on deviations, stocking of items in supply/ production / warehouse area, and standardizing equipment and cleaning production area.
  • Assists in determine root cause, implement a solution and a verification check to ensure the fix was effective.
  • Assists with creation and on-going maintenance of all pertinent equipment, policies, and procedures.
  • Produce product, media/buffer preparation, learn to troubleshoot equipment, participate in interviews on deviations, stocking of items in supply/ production / warehouse area, and standardizing equipment and cleaning production area.
  • Learn aseptic techniques, cell culture, recovery, purification, aseptic fill/finish (upstream and downstream).
  • Assists in producing clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
  • Supports the product requirements to ensure that all products are produced according to plan. Learn cGMP and cGDP and ensure cGMP documentation is being filled out correctly, training is current, and all Quality requirements are being followed.
  • Maintains quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process.
  • Partners with Quality to ensure a quality and compliant manufacturing environment.
  • Assists the technical operations team to resolve any issues related to production.
  • Other related duties as assigned.

Qualifications

  • Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent experience.
  • Excellent oral and written communication skills.
  • Entry level into the biopharmaceutical based GMP manufacturing operations, no experience necessary.
  • Ability to routinely lift over 35 lbs.
  • Ability to work alternate 12-hour shifts and weekends.
  • Approximately 10% travel.

 

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

 

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

 

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!  Imagine what you could do here at Novartis!

 

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.  Additionally, 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.

 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

 

Vaccine Policy:

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.

 

#LI-CM1

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