Senior Scientist, Technical Development - Downstream

Location
Durham, NC, US
Posted
Jun 05, 2021
Ref
6004
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Imagine\u2026 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 Scientist, Technical Development, is responsible for contributing to the development of the manufacturing platform. This role actively supports internal and external organizations to plan, execute, and document experiments that define the process and transfer the process to the clinical and commercial sites.

Responsibilities
  • Contributes process, analytical, and characterization knowledge in support of the production of Novartis Gene Therapies products, including the raw materials needed to make them.
  • Supports Process Owner team on process-related issues at internal sites, as well as with external partners. Serve as individual contributor to complete studies of moderate scope.
  • Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
  • Develops, implements, and maintains platform processes, planning to avoid delays, to enable the team to deliver a robust and effective product and manufacturing process.
  • Participates in the collection and interpretation of data. Support trending and monitoring of critical quality attributes/ process parameters to maintain product quality and to control process drift.
  • Supports the completion of time-sensitive studies at internal and external partners while capturing related data and knowledge, to advance the development of products from Research to Development, and on to GMP manufacturing.
  • Support Process Owner in identifying and implementing potential process improvements in conjunction with cross-functional teams.
  • Documents changes/updates to manufacturing processes.
  • Reviews and provides feedback and technical/scientific support on project deliverables (e.g. studies, protocols, reports, etc.).
  • Complete requisite training on all applicable policies and procedures related to the job function.
  • Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
  • Other related job duties as assigned.

Qualifications
  • Bachelor's degree in biochemistry, chemical engineering, bioengineering, or related technical field, with 8 years' experience, Master's with 6 years' experience, or PhD with 4 years' experience in biopharmaceutical based GMP manufacturing operations including direct experience in process development and/or tech transfer.
  • Excellent oral and written communication skills. Strong technical writing ability required.
  • Working in a team environment, with excellent communication and organizational skills.
  • Proven expertise with cell culture, recovery, purification, analytics, and/or aseptic fill/finish processes and technologies.
  • Ability to effectively and efficiently analyze and interpret data to further progress development strategies.
  • Proficient in study design, study execution, data analysis/interpretation, and documentation to progress development strategies.
  • Proven ability to coordinate among groups of scientists and contributors to a common goal.
  • Working knowledge in DOE is a significant plus
  • Experienced in GMP Operations and Quality.
  • Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment.
  • Ability to work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
  • Ability to exercises independent judgment in methods, techniques and evaluation criteria for obtaining results.
  • Creates formal networks involving coordination among groups.
  • Approximately 10% travel


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!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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.

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.

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