Process Development Intern-Durham

Location
Durham, NC, US
Posted
Feb 04, 2021
Ref
5868
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Technical Research & Development Department (TR&D) drives the advancement of the Novartis Adeno-associated virus (AAV) production platform across multiple manufacturing and development sites and manages the development, scale-up, transfer, optimization and characterization of processes for the clinical and commercial manufacturing of both new and licensed Novartis gene therapy products. Specific responsibilities of the TR&D department include ensuring the ongoing comparability of existing processes to filed parameters and performance, providing technical expertise/support to understand and continuously improve manufacturing processes, and designing next-generation process platforms through the identification, evaluation and strategic adaptation of new technologies into our gene therapy manufacturing processes. Fundamentally, the work we accomplish in TR&D ensures that manufacturing processes are robust, compliant & efficient while developing, advancing and incorporating new gene therapy manufacturing technology that drives the competitive business advantage that enables Novartis Gene Therapies to serve our patients.

The Process Development Intern supports laboratory operations in process design, experimental design & execution, scale model development & management, investigational testing for manufacturing operations support, platform development project planning & execution and therapeutic product program development support in addition to assisting the activities of scientific & engineering staff. The PD Intern, operating under the direct supervision of more senior scientists and engineers, executes and documents experimental procedures in support of process development activities supporting investigational, clinical and commercial gene therapy programs including but not limited to new process design, process proof of concept through characterization studies in alignment with program strategy, pre-clinical materials generation, direct clinical & commercial GMP operations support, scale-up studies scale model demonstration through qualification, raw materials and process pool evaluations in addition to process optimization & improvement studies. Laboratory operations support process development activities in drug substance (upstream, intermediate and downstream), drug product (formulation, filling, packaging and labeling) and critical raw materials, as well as media and buffer manufacturing.

Responsibilities
  • Participates in process development efforts under the direction of more senior engineers and scientists.
  • Executes projects within the TR&D Laboratory to enhance AAV production and capture technology capability and performance.
  • Under the direction of senior colleagues and individual manager, executes development studies related to process development and scale-up.
  • Drives results and generates innovative solutions, takes accountability to actively support solving scientific problems and driving their resolution.
  • Supports active pre-clinical, clinical and commercial manufacturing through laboratory studies designed to illuminate fundamental process performance (e.g. NOR & PAR setting, CPP edge of failure, impurity clearance performance).
  • Develops data that supports the authoring of technical reports of studies in support of process development activities such as Tech Transfer, unit operation design through characterization and Quality attribute impact assessments.
  • Ensures all documentation and reports are accurate, complete, and suitable for use in summary reporting.
  • Analyzes and interprets data to understand the fundamental phenomena at the heart of the investigation at hand and inform next steps.
  • Fosters a team environment committed to the principles of scientific excellence.
  • Completes requisite training, as well as applicable policies and procedures, related to the job function.

Qualifications
  • Enrolled in accredited university degree program pertaining to Chemical Engineering, Biochemical Engineering or a related technical field and has completed at least 2 years of applicable academic program requirements.
  • Understanding of Design of Experiment principles, basic knowledge of lean laboratory implementation (e.g. 6S) and exposure to laboratory biosafety practices is a plus.
  • Limited awareness of and/or basic knowledge of one or more biopharmaceutical production and purification processes such as cell culture, chromatographic separation, depth filtration, precipitation & flocculation, tangential flow filtration, adventitious viral clearance, ultracentrifugation, and impurity clearance is an advantage.


The level of this position will be based on the final candidate's qualifications.

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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