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Senior Formulation Scientist

2 months ago

California, United States HireMinds Full time
Job Summary

We are seeking a highly experienced Senior Scientist, Formulation to lead our efforts in solid oral formulation and process development. As a key member of our team, you 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.

Key Responsibilities
  • Formulation Development: Lead the design and development of solid oral dosage forms, from early research stages through late-stage clinical development.
  • Process Development: Oversee drug discovery activities related to lead optimization, pre-formulation, and formulation development.
  • Manufacturing: Manage the process development and scale-up of drug candidates, ensuring successful manufacturing of clinical materials.
  • Collaboration: Collaborate with external Contract Development and Manufacturing Organizations (CDMOs) to develop efficient and scalable manufacturing processes for oral dosage forms.
  • Regulatory Compliance: Contribute to the preparation of global Chemistry, Manufacturing, and Controls (CMC) regulatory submissions (INDs, IMPDs, NDAs).
  • Problem-Solving: Independently troubleshoot challenges and work efficiently with strong organizational skills.
Requirements
  • Education: MS/PhD in a relevant scientific discipline with 7-10+ years of experience in small molecule or peptide formulation development.
  • Expertise: Expertise in oral formulation development, including knowledge of excipients and their roles in formulation.
  • Technological Knowledge: Proficient in modern oral drug delivery technologies and complex formulations aimed at enhancing the bioavailability of small molecules or peptides.
  • Knowledge of Dosage Forms: Knowledge of various oral dosage forms, including tablets (immediate release, delayed, controlled release), capsules (hard-shelled, liquid-filled), and softgels.
  • Process Development and Manufacturing: Experience in the process development and manufacturing of oral dosage forms, including tableting, coating, granulation, and blending.
  • Physicochemical Characterization: Skilled in the physicochemical characterization of oral dosage forms, including dissolution, assay, stability, tablet hardness, and content uniformity.
  • Experimental Design: Understanding of experimental design, such as Design of Experiments (DoE) and Quality by Design (QbD) principles, for process scale-up and qualification.
  • Chemical and Physical Characterization: Experience in the chemical and physical characterization of new chemical entities, including solubility, particle size, stability, and BCS classification.
  • Analytical Techniques: Basic knowledge of analytical techniques, such as HPLC, DSC, FT-IR, TGA, and microscopy.

Full job description available for selected candidates.