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 Scientist I, Analytical Development – BioAssay, initiates, directs and executes the Development and optimization of cell-based potency and other functional bioassays in a team environment of phase-appropriate bioassays that are used for drug substance and drug product stability and lot release testing as well as characterization studies.
- Plan and execute experiments that contribute to bioassay development, optimization, qualification/validation of bioassays suitable for drug product stability studies and lot disposition.
- Optimize and troubleshoot cell-based assays as well as other plate-based assays using variety of platforms including but not limited to ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader in support of developing release and characterization assays for gene therapy products.
- Participate (or lead) method qualification/validation in a cGMP setting and may be involved in the method transfer to internal and/or external QC laboratories. Support tech transfer of methods to internal QC group and/or CROs.
- Assist in authoring of technical reports and SOPs; Prepares and document assay development, qualification and validation processes as well as SOPs, technical reports, summaries.
- Work with junior research associate on experimental design, troubleshooting, assay optimization and data interpretation as needed.
- Interpret and present data at group and department meetings.
- Collaborate within Bioassay group and provide support to collaborating functional groups as needed
- Monitors and evaluates completion of tasks and projects.
- Participate in exploratory assay development efforts to bring new technologies or assays to Analytical development
- Conducts work in compliance with cGMP, GDP, safety and regulatory requirements. Thoroughly analyzing data and ensuring the data quality. Provides analysis and evaluation of material and products at all stages of development process.
- Maintains broad knowledge of state-of-the-art principles and theories in Bioassay
- Makes major contributions to scientific literature and conferences.
- Serves as in-house and outside consultant.
- Interfaces with various departments.
- Other related job duties as assigned.
- Bachelor’s in Cell Biology, Molecular Biology or related discipline with 4 years’ experience or Master’s with 2 years’ experience or PHD with 0 years’ experience.
- Uses professional concepts and company’s policies and procedures to solve a variety of problems.
- Demonstrates potential for technical proficiency, scientific creativity, and collaboration with others and independent thought.
- Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
- Exercises judgment within defined procedures and practices to determine appropriate action.
- Receives general instructions on routine work, detailed instructions on new assignments.
- Normally receives general instructions on routine work, detailed instructions on new assignments.
- Familiar with cell-based assays as well as other plate-based assays using variety of platforms including but not limited to ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader.
- Ability to work in a fast-paced team-orientated environment.
- Excellent written and verbal communication skills.
- Experience with analytical and/or statistical software (e.g., JMP, Softmax Pro, XLfit, Gen5 etc.), is highly beneficial.
- Familiarity with virology is a plus.
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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