Senior Scientist, Analytical Development - Chem

Location
San Diego, CA, US
Posted
Jun 23, 2021
Ref
5932
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 Senior Scientist, Analytical Development - Chem, Develops/optimizes innovative analytical methods suitable for characterization and lot release of gene therapy products, participate in assay qualification/validation/transfer under cGMP requirements. Serve as SME to support regulatory commitments, IND filings and manufacturing process development and validation.

Responsibilities
  • Performs analytical chemistry research to develop/optimize HPLC, CE and MS based analytical assays for the characterization and lot release/stability monitoring of gene therapy products.
  • Qualifies/validates and transfers testing methodology used for manufacturing production in-process control and final drug substances/drug products, under cGMP settings.
  • Conducts testing of analytical samples in support of regulatory commitments, IND flings and manufacturing process charaterization/validation.
  • Conducts work in compliance with cGMP, safety and regulatory requirements.
  • Provides analysis and evaluation of material and products at all stages of development process.
  • Monitors and evaluates completion of tasks and projects.
  • Initiates, directs and executes chemistry efforts and strategies in research and/or development; also, plans and executes laboratory research.
  • Maintains broad knowledge of state-of-the-art principles and theories in analytical chemistry, protein chemistry, DNA chemistry and related disciplines.
  • Makes major contributions to scientific literature and conferences.
  • Serves as in-house and outside consultant.
  • May act as spokesperson on corporate research and development of patent applications. (this may be very rare)
  • Interfaces with various departments, serves as liaison among different functional groups for scientific discussions and analytical results presentation.
  • Proactively identifies assay issues, new assay needs and provide scientific suggestions and solutios
  • Authors/reviews SOPs, working instructions, technical protocols/reports
  • Supervise/mentor junior group members on daily laboratory work, experimental design, data interpretation and troubleshooting. Train new group members on basic analytical lab skills.
  • Actively participates and give suggestions on lab designing, instrument purchasing and strategic planning
  • Other related duties as assigned.

Qualifications
  • Bachelor's Analytical Chemistry or closely related field with 8 years experience or Master's with 6 or PHD with 4.
  • Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment.
  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Expert knowledge of scientific principles and concepts;Reputation as emerging leader in field with sustained performance and accomplishment.
  • Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
  • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • May determine methods and procedures on new assignments and may provide guidance to other lower level personnel.
  • Brings together a variety of backgrounds, combining analytical chemistry, biochemistry, biochemical engineering, protein chemistry and PhD expertise.
  • Skilled in cutting edge analytical techniques, including but not limited to HPLC, CE, FFF, Light scattering, spectroscopy and MS
  • Good working knowledge on analytical software including but not limited to Chromeleon, Empower, Chemstation, Astra, 32Karat, Xcalibur, Mascot, Byonic.
  • Good working practice and understanding on data integrity and compliance

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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