Scientist I, Analytical Development - Molecular Biology

Location
San Diego, CA, US
Posted
Mar 27, 2021
Ref
5461
Hotbed
Biotech Beach
Required Education
Other
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 Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

The Scientist I, Analytical Development - Mol Bio, Initiates, directs and executes the Development and optimization of phase-appropriate molecular biology assays for the lot release, stability testing and characterization of drug substance/drug product. Participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms.

Responsibilities
  • Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems.
  • Plans and executes laboratory research.
  • Initiates, directs and executes the development, optimization, qualification of robust molecular assays (i.e. NGS, qPCR, ddPCR and/or other molecular assay platforms) for DNA characteristics such as genomic integrity and residual packaged impurity DNA, suitable for the characterization and lot disposition of AAV-based gene products Conducts work in compliance with cGMP, safety and regulatory requirements.
  • Participates in activities such as RNA isolation, cDNA library construction, library amplification, genomic DNA isolation, polymerase chain reaction, and other standard molecular biology techniques.
  • Analyze data with applicable bioinformatics tools/scientifically sound interpretation and present data at group/departmental meetings.
  • Able to troubleshoot experiments based on thorough understanding of assay principles
  • Authoring of technical reports and SOPs associated with the molecular assays developed and qualified .
  • Communicates and partners with cross-interdisciplinary teams to include, but not limited to engineering, regulatory compliance, scientists and other professionals
  • Serve as SME of molecular assays in support of technology transfer of methods to internal QC group and/or CROs and subsequent trouble-shooting, as needed.
  • May act as spokesperson on corporate research and development and advise top management.
  • Collaborate within the Analytical Development-Molecular group and provide support to collaborating functional groups, as needed
  • Work with junior research associates on experimental design, troubleshooting, assay optimization and data interpretation, if applicable.
  • Maintains broad knowledge of state-of-the-art principles and theories.
  • Participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms.
  • Makes major contributions to scientific literature and conferences.
  • Other related job duties as assigned.

Qualifications
  • 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, 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.
  • Knowledge and hands-on experience with various molecular biology analytical methods .For example, DNA/RNA isolation, primer design, end point PCR, qPCR, qRT-PCR, droplet digital PCR, Sanger sequencing, next-generation sequencing (NGS)
  • Farmilar with various molecular biology and sequence analysis softwares. For example, Geneious, Applied Biosystems 7500, QuantaSoft
  • GXP experience preferred, but not required
  • Experience with bioinformatics programming (e.g., Python, R, etc.), is a plus
  • Experience with analytical and/or statistical software (e.g., JMP, Softmax Pro, XLfit, Gen5 etc.), is highly beneficial
  • Demonstrated proficiency in developing and optimizing molecular bioassays independently with limited guidance
  • Demonstrated ability to work in a fast-paced, team-orientated environment with aggressive timelines
  • Experience and understanding of phase-appropriate analytical assay development, qualification, and validation obtained from 1-2 years of experience in GxP environment is a significant plus, but not required
  • 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.

AveXis 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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