Scientist, Drug Product Development
Abide Therapeutics is seeking a highly motivated, experienced scientist to contribute to the identification and development of novel small molecule drugs targeting the serine hydrolase enzyme family. Abide’s mission is to develop innovative medicines that target serine hydrolases, one of the largest enzyme classes in nature with validated, but mostly untapped, therapeutic potential. Abide is a privately held biotechnology company. This position will be based in our San Diego, California laboratory.
If you thrive in a dynamic, fast-paced environment and enjoy creative and challenging work, Abide may be the company for you. We are currently seeking a Scientist, Drug Product Development to join our team.
In this role, the successful candidate will develop and optimize drug product formulations of our candidate molecules for human clinical evaluation and function as part of a cross-disciplinary team to advance compounds through clinical trials to commercial launch. This candidate will establish and manage interactions with contract manufacturing organizations (CMO) to enable the development and manufacturing of solid oral, parenteral, and pediatric dosage forms for clinical evaluation. Additionally, the successful candidate will contribute to preparing the drug product section of IND applications and investigational medicinal product dossiers in collaboration with consultants, QA specialists, and CMOs. The candidate will perform work to support lead optimization programs by designing appropriate formulation approaches for preclinical evaluation of lead molecules. The candidate will work independently, possess familiarity with US and EU regulatory requirements as well as ICH guidelines, and contribute to patent applications and publications as needed.
Experience and education requirements
- Ph.D. or equivalent in Pharmaceutical Sciences, Pharmaceutics, or related discipline with experience in formulation development within the pharmaceutical industry
- Experience in development of solid oral, parenteral and pediatric formulations preferred
- Knowledge of solid state chemistry, particle size management, and enhanced formulation technologies
- Experience with cGMP principles, drug product manufacturing, and setting process and product specifications
- Experience interacting with and managing CROs to develop and manufacture drug product preferred
- Experience with preparing drug product sections of INDs and IMPDs
- Experience or knowledge of clinical supply process, paradigms, and requirements a plus
- Strong collaboration skills within a cross disciplinary team setting
- Excellent oral and written communication skills; Strong presentation skills and the ability to communicate complex scientific concepts to a broad audience
- Outstanding problem solving, troubleshooting, and organization skills
- Proficient with computers and software such as Microsoft Office and other relevant software
- Both effective team player and strong individual contributor, flexible, and able to handle multiple tasks and deliver high quality results under tight timelines
For additional information about Abide Therapeutics, Inc. please visit our website at www.abidetx.com. In addition to a competitive compensation package with stock options, Abide also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability, and a 401(k) Plan. For consideration, please submit your resume and cover letter referencing job DPD2018.11.30 to email@example.com. Abide Therapeutics, Inc. is an EEO employer.