Senior Engineer, Manufacturing Science and Technology

Location
Durham, NC
Posted
Jul 02, 2022
Ref
2022-6625
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

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 Senior Engineer, Manufacturing Science and Technology, is responsible for leading process introduction and improvement activities for the drug substance (expansion, upstream and downstream) and/or drug product manufacturing processes used to manufacture gene therapy products at a site.

Responsibilities

  • Collection and interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements.
  • Serves as a scientific and technical lead for process-related issues and investigations at the facility.
  • Partners with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
  • Performs trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • 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 working with manufacturing, engineering and validation to implement those changes.
  • Provides technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports.
  • Partners with Technology Development to support tech transfer of new products and processes and ensure smooth transition from process development to 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 to resolve any issues related to production.
  • Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.
  • Other related duties as assigned.

Qualifications

  • Bachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 6 years of experience in support of biopharmaceutical manufacturing OR Master of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 4 years of experience in support of biopharmaceutical manufacturing  OR PhD in biochemistry, chemical engineering, bioengineering, or related technical field.
  • Preferred Experience: 6 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in aseptic fill/finish, cell culture, recovery, and/or purification.
  • Excellent oral and written communication skills.
  • Familiar with global regulations on devices, drugs, validation/qualification requirements.
  • Strong technical writing ability.
  • Proven ability to effectively lead and participate on teams.
  • May travel up to 10% - 15%.

 

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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