Sommario
purification, and/or aseptic fill/finish manufacturing processes used to manufacture gene therapy products at a site.
About the Role
Responsibilities:
- Supports the collection and interpretation of continued process verification data and collaborate with other departments on manufacturing related issues to drive resolution and process improvements.
- Serve as a scientific and technical representative for process-related issues and investigations at the facility.
- Performs trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
- 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 compliant manufacturing environment.
- Assists the technical operations team in resolving issues related to production.
- Partners with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
- Implements potential process improvements in conjunction with operations.
- Participates in start-up efforts of new equipment, software or processes in manufacturing.
- Assists in documenting changes/updates to manufacturing processes and partner with manufacturing, engineering and validation to implement those changes.
- Provides technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports.
- Utilizes small-scale production processes and scaled-down lab processes to enable process troubleshooting.
- Completes requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.
- May work on special projects related to development and improvement of business and/or manufacturing processes.
Requirements:
- Bachelor’s degree in biochemistry, chemical engineering, bioengineering, or related technical field with 4 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish, or related engineering field.
- Bachelor’s degree in biochemistry, chemical engineering, bioengineering, or related technical field with 3 years of direct Novartis GTx experience.
- Master of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field with 2 years of experience in support of biopharmaceutical manufacturing, or related engineering field.
- Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements.
- Strong technical writing ability.
- Proven ability to effectively participate on teams.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or 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.
