Purpose of Role:
This position reports to the Vice President of pharmaceutical development. The associate research associate/scientist will contribute to the ongoing efforts to develop first-in-class or best-in-class therapies for metabolic and endocrine disorders. This is an excellent opportunity for a highly driven professional to contribute and grow value of a clinical-stage pharmaceutical company.
This is not a remote position and is onsite at the Viking San Diego office.
Key Tasks & Responsibilities:
- Work with the internal discovery team to advance discovery candidates to clinical development.
- Provide technical support including preclinical, analytical, formulation development and clinical manufacturing/packaging activities at CDMOs.
- Collaborate with other functions within Viking Therapeutics to develop and implement regulatory documents (e.g., specifications) for the development, manufacture, release and labeling of drug substance and clinical trial material (CTM).
- Manage external CROs for outsourced development activities.
- Draft and/or review nonclinical, and chemistry and manufacturing control (CMC) regulatory documents.
- Remain current in the field via relevant scientific literature.
- A BS/MS/PhD in analytical chemistry, organic chemistry, physical chemistry, pharmaceutical sciences, or related scientific field is required.
Professional Skills & Experience:
- 3+ years of related industry experience in a CMC environment including drug substance and/or drug product development, production, testing and release.
- Experience in a virtual biotech setting working with external CDMO and CRO based resources for preclinical activities, production of drug substance and drug product, testing, and CTM labeling is a plus.
- Experience and familiarity in the CMC regulatory environment for early to mid-stage development.
- Working knowledge and familiarity of GMP/ICH regulations required.
- Working knowledge of quality by design and risk management is a plus. Knowledge of ICH Q8/Q9 and Q10 is preferred.
- Team oriented professional with excellent organization, communication, leadership and problem-solving abilities.
- Demonstrate ability to successfully coordinate multiple work streams and development efforts in a timely and economically responsible manner in a small start-up biotech company.