Sr Scientist ; Formulations

Position: Sr Scientist I (Formulations)
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* 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.
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* ESSENTIAL DUTIES AND 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.
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* SUPERVISORY RESPONSIBILITIES:

*** None
* * EDUCATION/EXPERIENCE/

SKILLS:

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* Education:

*** 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.
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* 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 Chromotography (HPLC), Fournier Transfer Infrared Spectroscopy (FTIR), Thermogravirmetric Analysis (TGA), and Differential Scanning Calorimeter (DSC), etc. is a plus.
** Knowledge/Skills/Abilities:
*** Knowledge of formulation development and process optimzation/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…