Scientist – Senior Scientist, Analytical Development.

Scientist – Senior Scientist, Analytical Development

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