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Senior Expert Science & Technology, Process Development
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation - Durham, NC
posted 2 months ago
About the position
The Senior Expert in Science & Technology will play a pivotal role in advancing cell and gene therapies by leading and supporting projects within the research and development drug product laboratory. This position focuses on enhancing manufacturing technologies, capabilities, and processes to support pipeline programs, ensuring compliance and safety in lab operations, and collaborating with cross-functional teams to facilitate tech transfers and regulatory filings.
Responsibilities
- Lead and support projects within the research and development drug product laboratory to enhance manufacturing cell and gene therapy technologies, capabilities, and processes.
- Independently plan, design, and perform cell and gene therapy drug product formulation and process development studies.
- Safely and compliantly execute lab operations for drug product process development studies.
- Collaborate with cross-functional groups to coordinate studies.
- Lead and support tech transfer of new products, technologies, and processes to ensure smooth transition from process development into GMP manufacturing.
- Evaluate and summarize data using analytical methodologies, interpreting results, and recommending options for future experiments.
- Independently author technical documents (SOPs, protocols, basic scientific reports) and present results of development studies.
- Provide support for regulatory filings.
- Advance drug product process innovations as a technical lead through cross-functional collaboration teams across Novartis sites and organizations.
- Leverage strong understanding of AAV and LVV drug product fundamentals to evaluate and introduce new technologies.
Requirements
- Bachelors in biological sciences, pharmaceutical sciences, bioengineering, chemical engineering or related technical field with 6 years relevant experience; Masters with 4 years of experience, or PhD with 2 years of experience.
- Comprehensive experience with a variety of drug product process development experience such as formulation development, sterile filtration, container closure integrity testing (CCIT), aseptic fill-finish, and drug delivery.
- Good knowledge or experience of laboratory skills and technical tools.
- Ability to motivate peers and staff, fostering an innovative and collaborative culture of continuous improvement and operational excellence.
- Provide technical/scientific support in process development and qualification efforts in pre-clinical and clinical manufacturing.
- Ability to effectively and efficiently analyze and interpret data to further progress development strategies.
- Excellent oral and written communication skills with project management experience.
- Strong technical writing ability.
Nice-to-haves
- Experience with 3rd parties (equipment vendors, and contract manufacturing insourcing/outsourcing) is preferred.
- Working knowledge and experience with Design of Experiments (DoE) is preferred.
- Working knowledge of FDA regulations and GMP systems is preferred.
- Knowledge of viral gene therapy and previous experience with adeno-associated virus (AAV) and/or lentiviral vectors (LVV) formulation and process development is preferred.
Benefits
- 401(k) eligibility
- various paid time off benefits, such as vacation, sick time, and parental leave
- sign-on bonus
- restricted stock units
- discretionary awards
- full range of medical and financial benefits
