A growing company is seeking an individual to provide scientific, technical, and hands-on leadership in support of enabling technologies in peptide delivery and pharmaceutical development. The qualified candidate will:
- Provide high-level strategic knowledge in identifying and implementing enabling technologies for peptide delivery systems and the development of novel formulations.
- Be responsible for peptide formulation development from lead optimization to clinical development. The candidate should have experience and/or knowledge in formulation and pre-formulation research, formulation development, and process selection with enabling technologies.
- Provide technical input and oversight related to formulations, including development work outsourced to CDMOs and contract testing laboratories.
- Oversee pre-formulation and research formulation activities.
Required Skills:
- Expertise in drug delivery formulations to enhance peptide oral bioavailability.
- Formulation and process development of biologics and/or peptides to be delivered through oral and injectable routes, including controlled release and depot formulations.
- Knowledge of analytical skills related to identified formulations.
- Excellent communication (both verbal and technical) and interpersonal skills.
Essential Functions:
- Must have current knowledge of peptide delivery systems (oral and subcutaneous).
- Plans, designs, implements, and analyzes laboratory experiments to advance scientific knowledge of drug formulations.
- Must have a strong understanding of the principles and practices of chemistry or pharmaceutical sciences and be able to integrate and apply this knowledge effectively to formulate new peptides.
- Works closely with senior scientific teams to advance the development of state-of-the-art drug delivery techniques.
- Represents pharmaceutical sciences in cross-functional project teams for both drug discovery and development.
- Presents, interprets, and draws conclusions from data for presentations to project teams and senior management.
- Demonstrates ability in developing methods, techniques, and evaluation criteria for obtaining results and interpreting experimental outcomes.
- Thinks critically and creatively, works independently, determines appropriate resources for resolving problems, and has strong organizational and planning skills.
- Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations.
- Knowledge of cGMP principles and CDMO oversight for GMP manufacturing is preferred.
- Authoring contributions to regulatory submissions is a plus.
- Ability to travel domestically and internationally is expected.
Knowledge, Experience, and Skills:
- 10+ years of experience in small molecule, biologics, and/or peptide pre-formulation & development with a Ph.D. in a related scientific discipline.
- Expertise in drug delivery formulations to enhance peptide oral bioavailability.
- Excellent writing and communication skills.
- Strong interpersonal skills and experience in interfacing with CMC team members and R&D project teams.
The base pay range for this position at commencement of employment is expected to be between $195,000 and $235,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.