Position Description
Nurix is seeking an experienced, independent, and highly motivated individual to support the late-stage drug product development through approval of NX-5948 and the expansion of the Nurix pipeline. This Senior Scientist, Pharmaceutical Development will work closely with the CMC team and colleagues in cross functional departments to manage development and production activities at CROs and CDMOs. Position reports to Director, Pharmaceutical Development.Responsibilities will include but are not limited to:
- Oversee technical activities at CDMOs for development of solid oral drug products, including tech transfer, process development, CTM production, troubleshooting, QbD and PAR studies, registration batch production, and process validation.
- Effect phase appropriate refinements of manufacturing processes, conduct robustness studies, and identify critical quality parameters to develop and streamline a manufacturing process that is scalable for potential commercialization. Conduct risk assessments/FMEAs through process development and pre-validation.
- Establish measures and metrics to define manufacturing performance and provide recommendations to management to optimize operations.
- Works collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure a high-quality level of cGMP manufacturing excellence.
- Review and approve master batch records and validation protocols/reports required for drug product manufacturing.
- Author and review technical protocols, development reports, and Drug Product CMC sections for regulatory submissions (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers).
- On-site presence at CDMOs during critical meetings and manufacturing.
Required Qualifications
- PhD in chemistry, pharmaceutics, engineering, or related field with at least 5 years relevant industrial experience orMS with at least 8 years working experience in formulation, chemical engineering, or related area.
- Minimum of 3 years' experience in managing outsourced development activities.
- In-depth knowledge and demonstrated expertise and accomplishment in small molecule oral solid dose form (capsules and tablets) characterization and manufacturing process development; experience with amorphous solid dispersion-based formulations a plus
- Strong knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales including cGMP manufacturing.
- Knowledgeable with Registration and Process Validation campaigns including designing and executing FMEA/DOE. Also, experience with product readiness for launch.
- Familiar with statistics software (Minitab or JMP), familiar with DOE design and data analysis
- Excellent written and oral communications skills
- Ability to travel up to 25% of time
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