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 Sr. Associate Engineer, Manufacturing Science and Technology assists with the maintenance and improvement activities for the cell culture, recovery, purification, and/or aseptic fill/finish manufacturing processes used to manufacture gene therapy products at a site.
- Supports the collection and interpretation of continued process verification data and collaborates with other departments on manufacturing related issues to drive resolution and process improvements.
- Generates protocols and reports for technical studies.
- Serves as a point of contact for initial triage of on the floor manufacturing issues.
- Provides on floor support and observation of process execution to provide recommendations for consistency and improvement. Identifies gaps between floor execution and process design and descriptions.
- Participates with MFG on Operational Excellence and continuous improvement projects.
- Performs data analysis to identify process drift.
- Consults with Quality to ensure a compliant manufacturing environment.
- Assists the technical operations team in resolving issues related to production.
- Implements process improvements with direction from Sr. MSAT personnel.
- Assists in documenting changes/updates to manufacturing processes and partner with manufacturing, engineering and validation to implement those changes.
- Participates in project execution and deliverables with support and guidance of Sr. MSAT personnel.
- Participates in start-up efforts of new equipment, software or processes in manufacturing.
- 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.
- Other related duties as assigned.
- Bachelor's degree in biochemistry, chemical engineering, bioengineering, or related technical field with 2 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish.
- 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.
- Excellent oral and written communication skills.
- Up to 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.
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 firstname.lastname@example.org 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.
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