Sr Scientist I (Formulations)

Role Summary

The Senior Scientist I will be responsible for early and late stage drug product development activities ranging from formulation, process development, optimization, and scale-up of small molecule oral dosage form. This individual will oversee and coordinate activities in lab and provide support in technology transfer, scale-up, process validation, and commercialization. This individual must have a “take charge”, “lead by example” attitude, and excellent communication skills. The applicant also must possess a solid track record of working in a high potency lab, deep underlying technical problem-solving skills and creative thinking in small molecule oral solid dosage form development. He/she will be working in a fast pace internal/external cross functional team environment, be able to present technical data to leadership team, and support manufacturing of CTM batches at third party manufacturers for early and late stage programs.

Responsibilities

• Develop oral solid dosage form for oncology products using various formulation technologies.
• Design formulation development studies including lab scale and scale-up manufacturing processes for oral solid dosage form.
• Identify, critical quality attributes and process parameters and implement appropriate process controls for the manufacturing process.
• Work in high potency lab using PAPR and appropriate lab safety procedures.
• Troubleshooting skills in formulation/process issues for oral solid dosage forms.
• Apply methodical approach in selection of vehicles, excipients and/or new technologies appropriate to prepare formulations of novel investigational small molecules to support non-clinical studies.
• Apply statistical design of experiments to optimize and scale-up formulations and manufacturing process.
• Knowledge of enabling technologies such as solid dispersion, lipid or microemulsion, oral liquid formulation is a plus.
• Participation in project teams and internal/external collaborations, and preparation and review of regulatory/CMC documents.
• Possess excellent writing and verbal communication skills and strong interpersonal skills.

Qualifications

• BS/BA degree in pharmaceutics, or pharmaceutical sciences, bioengineering, biophysics, chemical engineering and seven years of related experience; or,
• MS/MA degree in pharmaceutics, or pharmaceutical sciences, bioengineering, biophysics, chemical engineering and five years of related experience; or,
• PhD in pharmaceutics, or pharmaceutical sciences, bioengineering, biophysics, chemical engineering, and zero or more years of related experience; or;
• Equivalent combination of education and experience.

Experience

• Experience in Pharmaceutical/Biotech industry preferred.
• Must have proven skills in the areas of solid oral drug product formulation development.
• Hands on experience in high shear granulation, roller compaction, direct compression, aqueous and solvent-based coating is required.
• Experience with statistical tools to design and evaluate experiments for formulation and process development preferred.
• Experience with other dosage forms or advanced formulations (e.g. controlled release) is a plus.
• Operation of various scientific instrumentation such as, High Performance Liquid Chromatography (HPLC), Fourier Transform Infrared Spectroscopy (FTIR), Thermogravimetric Analysis (TGA), and Differential Scanning Calorimeter (DSC), etc. is a plus.

Knowledge/Skills/Abilities

• Knowledge of formulation development and process optimization/scale up of solid oral dosage forms.
• Strong knowledge and experience of the various phases of drug development for oral dosage forms is required.
• Familiarity and working knowledge of current Good Manufacturing Practices (cGMP)/International Conference on Harmonization (ICH) regulations, with experience working in a GMP facility is required.
• Proficient with broad use of computer applications such as MS Office.
• Applies strong analytical and excellent verbal and written communication skills.
• Identifies and implements methods and procedures to achieve results.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.

Working Conditions

• Environment: Primarily working in office
• Travel required ‚Äì 10% of domestic/international travel required