Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. This is a day shift role.
Novartis Gene Therapies is dedicated to developing and commercializing gene therapies for patients and families devastated by rare and life-threatening neurological genetic diseases.
*Performs commercial and clinical manufacturing operations on the site, including purification (downstream), fill-finish (drug product), media/buffer preparation, and any additional supporting activities.
*Learns to troubleshoot equipment, participates in interviews on deviations, partners with other business units to assist in manufacturing led deviations, standardizes equipment, and cleans production area.
*Assists in determining root cause, implementing solutions and verifying solutions are effective.
*Assists with the creation and on-going maintenance of all pertinent equipment, policies, and procedures.
*Learn and perform aseptic techniques applicable to cell culture, recovery, purification, aseptic fill/finish (upstream and downstream).
*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 the Quality department to ensure a compliant manufacturing environment.
Commitment to Diversity & Inclusion:
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:
Role Requirements
For BioProcess Engineer I – Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field or 2 years equivalent experience;
*For for BioProcess Engineer II – Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 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;
*For BioProcess Engineer III – Bachelor of Science Degree in Biology, Chemistry, Biotechnology or applicable field and 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; OR six (6) 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
*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.
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