BioProcess Engineer I/II/III Downstream (2-2-3 am shift)

Technical Operations                 ·               USA                ·              Full time

BioProcess Engineer I/II/III Downstream (2-2-3 am shift)

• Job ID : 388315BR
• Dec 08, 2023
• USA

About the Role

The BioProcess Engineer I downstream/Drug Product is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the plant/site. The level of the role will be determined by the years of relevant experience.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Novartis Gene Therapies is dedicated to developing and commercializing gene therapies for patients and families devastated by rare and life-threatening neurological genetic diseases.

• 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.

Diversity & Inclusion / EEO

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

• Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
• Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098

Role Requirements

• Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent experience for BioProcess Engineer I; or for BioProcess Engineer II-III 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 2+ years experience in the manufacture of Novartis Gene Therapies product
• 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.

Division: Operations

Business Unit: NOVARTIS GENE THERAPIES

Location: USA

Site: Durham, NC

Company / Legal Entity: Novartis Gene Therapies

Functional Area: Technical Operations

Job Type: Full Time

Employment Type: Regular

Shift Work: Yes

Job ID : 388315BR

Technical Operations, Operations, USA

Please click here to apply.