Scientist II, Analytical Development - Bioassay

Location
San Diego, CA, US
Posted
Jul 18, 2021
Ref
6131
Hotbed
Biotech Beach
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 Scientist II, 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.

Responsibilities
  • 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.
  • 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.

Qualifications
  • Bachelor's Cell Biology, Molecular Biology or related discipline with 6 years experience or Master's with 4 years experience or PHD with 2 years experience.
  • Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
  • Expert knowledge of scientific principles and concepts.
  • Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
  • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Normally receives no instructions on routine work, general instructions on new assignments.
  • Farmilar 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.

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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