BioProcess Engineer ll - Upstream (Nights)

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 II, is responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process.

 

Please note: 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

• Produces clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
• Works 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.
• Supports 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.
• Participates in information requests for FDA and internal audits of the manufacturing facilities.
• Maintains quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process.
• 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 quality and compliant manufacturing environment.
• Assists the technical operations team to resolve any issues related to production.
• Other relates duties as assigned.

Qualifications

•  

• Bachelors of Science Degree in Biology, Chemistry, Biotechnology or applicable field with 2 years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment; Or four (4) years' experience in cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish environment in lieu of degree.  Or Bachelors' degree in Biology, Chemistry, Biotechnology or applicable field with 1 year experience in the manufacture of Novartis Gene Therapies product;
• Direct experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems.
• Strong technical writing ability.
• Proven ability to effectively lead and participate on teams.
• Ability to routinely lift over 35 lbs.
• 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.

 

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