Organization:
DermBiont aims to chart a path to become the leading targeted topical therapeutics development company by leveraging decades of combined team experience to select and develop first-in-class assets with the highest probability of success in the clinic and to run efficient clinical trials at a fraction of industry-standard timelines and budgets. The company is advancing targeting topical small molecules for the treatment of skin diseases, beginning with SM-020 for the treatment of seborrheic keratosis and SM-030 for the treatment of hyperpigmentation disorders of the skin. DermBiont works continually to create an environment that facilitates and empowers our employees to do their best work.
Overview:
The small molecule CMC team is seeking a highly motivated Senior Scientist for Drug Product Development who can work collaboratively in a cross-functional team environment. The responsibility includes activities critical to the development of Dermbiont’s small molecules programs including (1) leading pre-formulation characterization and formulation development, (2) clinical stage formulation and manufacturing process development, (3) supporting regulatory filling at various development stages. The primary focus of this role will currently be on topical dosage form development but may involve the development of other dosage forms in the future.
Key responsibilities:
- Development of formulations and manufacturing processes for new drug product products through collaboration with formulations/process development experts at contract development/manufacturing companies
- Responsible for literature research (publications, company information, patents), leading to the planning, conceptualizing, and preparation of formulations independently with minimal direction or supervision
- Coordinate and oversee manufacturing and packaging activities, for clinical trial and stability batches at CDMOs
- Prepare requests for proposals and support drug product vendor selection activities.
- Implement innovative and state-of-the-art technologies on formulation and process development to support efficient and cost-effective drug product manufacturing.
- Manage numerous projects at different phases of development, from proof of concept through FDA submission.
- Support authoring and reviewing of regulatory documents for IND, NDA, MAA, and other potential global regulatory agencies.
- Provide functional area updates (oral and written) in a clear and concise manner.
Qualifications:
- MS degree in Pharmaceutical Science, or related fields with at least 4-5 years of direct industrial experience (Ph.D. with 0-2 years) in formulation development and drug product manufacturing
- Hands-on experience in pre-clinical formulation development working with research to formulate poorly water-soluble compounds to maximize exposure
- Hands-on experience in HPLC/UPLC analysis and method development is preferred.
- Experience in topical formulation development for small molecules, IVRT, IVPT, compatibility, and other physical testing.
- Experience in drug product manufacturing, formulation, and process development DOE (QbD) studies is a plus.
- Experience in cGMP regulations, deviation and OOS investigations, root-cause analysis, CAPA, change control and QC practices, ICH, FDA, and EU guidelines is preferred
- Experience in authoring development/technical reports and IND or related regulatory documents to support marketing applications to the FDA and global regulatory agencies is a plus
- Excellent oral and written communication skills and flexibility to work in a fast-paced team environment. Ability to prepare technical correspondence and present to research, CMC, and department meetings.
- Willing to travel as needed to support ongoing development activities including overseeing the production of clinical trial material to support on-time start of clinical studies
