Formulation Research Associate to Principal Investigator Level
| Job
code: |
841 |
| Job Category: |
Process Development |
| City: |
California |
Job Description:
Formulation Research Associate to Principal Investigator Level
We are currently seeking talented individuals with expertise in process development of solid dosage formulation to join our growing Pharmaceutical Development team. Responsibilities: - Develop robust, stable, and bioavailable formulations to support Phase II and III clinical studies and commercialization.
- Develop and scale-up robust processes for the production of solid dosage formulations.
- Identify and collaborate with CROs/CMOs in the execution of clinical batches, and scale-up of formulation and processes to support late phase clinical studies and commercialization.
- Identify and develop platform technologies for sustained release formulations.
- Collaborate with QA and Analytical functions towards timely generation of regulatory documents.
Qualifications and Other Required Knowledge and Skills: - A BS/MS/PhD in Chemical Engineering, Chemistry, Materials Science or Pharmaceutical Sciences is required, with 10+/6+/3+ years of related industry experience in formulation design and development and process development and scale up.
- An in-depth knowledge and research expertise in the field of solid oral dosage formulation is strongly desired, from conception to full commercial utility.
- Strong knowledge of roller compaction and/or fluid bed granulation required.
- Working knowledge of sustained release formulations preferred.
- Familiarity and working knowledge of GMP/ICH regulations required, with experience working in a GMP facility preferred.
- Ability to work independently, with excellent organizational, communication, leadership and problem solving abilities.
- Working knowledge of quality by design and risk management is strongly desired. Knowledge of ICH Q8/Q9 and Q10 is preferred.
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