JOIN OUR TEAM.

At Regulus, we have fostered a culture that values scientific rigor, creative problem solving, collaboration across departments and disciplines, and persistence in the face of obstacles.

Above all else, we are inspired by the many individuals worldwide affected by genetic kidney diseases and other genetically-based, orphan diseases.

Located in San Diego, California, we are a dedicated team of scientists, researchers, and biotech professionals committed to learning and growth, and to the patients we serve.

Current Openings.

Scientist – Senior Scientist, Analytical Development

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We are currently seeking an experienced Scientist – Sr. Scientist of Analytical Development to join our team to advance our compounds through preclinical and clinical development.

Essential Duties and Core Responsibilities:

  • Develop and implement analytical methods for research oligonucleotides, oligonucleotide conjugates and raw materials.
  • Ensure CofAs, stability protocols, and stability timepoints for on-going drug substance, and drug product are up-to-date for on-going drug substance, and drug product.
  • Develops, qualifies and transfers mass spectrometry and HPLC based CMC methods (sequence verification, impurity characterization, structure confirmation) to CMOs for new molecules entering development.
  • Ensures CRO/CMOs are using stage appropriate analytical methods and protocols in compliance with relevant regulatory standards.
  • In conjunction with team members, sets specifications of raw material, drug substance and drug product used in preclinical and clinical studies.
  • Provides analytical expertise for manufacturing, supply chain, handling, and / or investigations (deviations, OOS, root cause analysis).
  • Develops stability protocols (including ICH), monitors and trends stability data, and makes judgements on test article integrity.
  • Contributes to characterization, analytical, stability and other sections of regulatory submissions.
  • Provides internal support for FDA, EMEA, ICH guidelines and regulations on CMC issues.
  • Ensures project goals and deadlines are met and results are delivered with high quality in a time sensitive manner.
  • Reviews scientific literature, patents, scientific abstracts to stay current with the latest developments in the field.

Experience and Qualifications

  • D. or MS in Chemistry (Analytical Chemistry, Organic Chemistry, Biochemistry, etc.,) with 2 to 3 years (for Ph.D. candidate) or 4 to 5 years (for MS candidate) of relevant industrial or academic experience.
  • Extensive experience in structural characterization of oligonucleotides (and small molecules that are related to oligonucleotide chemistry) by means of LC-MS is strongly desired.
  • Substantial experience in other various chromatographic and spectroscopic techniques, such as NMR, HPLC (with MS, UV-vis, ELSD detection), UV-Vis, DLS, viscosity, osmolality, etc.
  • Experience with identification and characterization of both process and stability related impurities.
  • Direct relevant experience in method development and validation and use of appropriate analytical methodologies for miRNA.
  • Experience with reference standard preparation, characterization, certification and recertification.
  • Knowledge of analytical method development for preclinical, GLP and GMP stages as well as understanding of regulatory and quality requirements.
  • Experience with CMC regulatory aspects for oligonucleotide drug substance and drug product.
  • Knowledge of cGMP, cGLP, ICH, USP and FDA guidelines and regulations with respect to the development of analytical methods for oligonucleotides.
  • Proven ability in taking initiative to learn new technologies and techniques.
  • Excellent written and verbal communication skills.
  • Proven record of scientific excellence through publications in peer-review journals.
  • Excellent leadership, verbal/written, and interpersonal skills. Works efficiently with others to accomplish goals and resolve problems.  Encourages cooperation, collaboration, and co-ownership of processes, problems, and solutions.

 

Excellent salary and benefits package offered.

For immediate consideration, please apply to careers@regulusrx.com

You can visit our website to find out more about our company and culture: www.RegulusRx.com.

NO PHONE CALLS PLEASE.  PRINCIPALS ONLY

Regulus Therapeutics, Inc, is proud to be an EEO Employer

Benefits.

Regulus provides a competitive benefits package that includes a choice of health, vision, and dental insurance, life insurance, flexible spending accounts, 401K plan, vacation and stock options.

We believe that you, as an employee, matter above everything else. We back that statement up continuously with a unique approach to providing you with great benefits and valuable resources. Our benefits packages and resources are designed to support you in creating the life and work style that brings your best to your community, your family and Regulus’ mission of addressing significant unmet medical needs.

Most of our benefits cover employees who work at least 30 hours a week and their eligible dependents. Eligible dependents include:

  • A spouse or domestic partner
  • Children (biological, step, foster, adopted or legal charge) up to age 26
  • The majority of our benefits become effective immediately on the date of hire without any pre-existing condition exclusion (temporary employees, contractors, interns and co-ops are not eligible for benefits).

In addition to an array of health and financial benefits and learning opportunities, we offer competitive compensation and bonus programs that reward you for your contributions toward achieving the company’s mission and strategic goals. We also provide you with a wide range of services designed to help make life easier while you are at work, so you can spend your free time doing more of the things you enjoy most.