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. The individual will oversee and coordinate activities in lab and provide support in technology transfer, scale-up, process validation, and commercialization.
Requirements
- 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.
- 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.
- Participation in project teams and internal/external collaborations, and preparation and review of regulatory/CMC documents.
- Excellent writing and verbal communication skills and strong interpersonal skills.
Benefits
- Comprehensive employee benefits package
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year