Senior Scientist, Formulations
SF Bay Area (East Bay)
Our client is looking for an experienced professional to lead efforts in solid oral formulation and process development. This individual will play a critical role in advancing the pharmaceutical development of oral dosage forms, providing both scientific and technical expertise in formulating drugs for clinical development.
Responsibilities:
- Lead the design and development of solid oral dosage forms, from early research stages through late-stage clinical development.
- Oversee drug discovery activities related to lead optimization, pre-formulation, and formulation development.
- Manage the process development and scale-up of drug candidates, ensuring successful manufacturing of clinical materials.
- Collaborate with external CDMOs to develop efficient and scalable manufacturing processes for oral dosage forms.
- Contribute to the preparation of global CMC regulatory submissions (INDs, IMPDs, NDAs).
- Independently troubleshoot challenges and work efficiently with strong organizational skills.
Qualifications:
- MS/PhD in a relevant scientific discipline with 7-10+ years of experience in small molecule or peptide formulation development.
- Expertise in oral formulation development, including knowledge of excipients and their roles in formulation.
- Proficient in modern oral drug delivery technologies and complex formulations aimed at enhancing the bioavailability of small molecules or peptides.
- Knowledge of various oral dosage forms, including tablets (immediate release, delayed, controlled release), capsules (hard-shelled, liquid-filled), and softgels.
- Experience in the process development and manufacturing of oral dosage forms, including tableting, coating, granulation, and blending.
- Skilled in the physicochemical characterization of oral dosage forms, including dissolution, assay, stability, tablet hardness, and content uniformity.
- Understanding of experimental design, such as Design of Experiments (DoE) and Quality by Design (QbD) principles, for process scale-up and qualification.
- Experience in the chemical and physical characterization of new chemical entities, including solubility, particle size, stability, and BCS classification.
- Basic knowledge of analytical techniques, such as HPLC, DSC, FT-IR, TGA, and microscopy.
Full job description available for selected candidates.
