Formulation Development Specialist
3 weeks ago
**About the Role:**
We are seeking a highly skilled Process Development Associate to join our team at Randstad Life Sciences in Thousand Oaks, CA.
**Job Summary:**
- The successful candidate will be responsible for executing small molecule formulation experiments to support the development of oral solid dosage forms for early-stage clinical studies.
- You will contribute to the creation and optimization of digital platform capabilities while supporting experimental efforts to design and optimize drug product formulations and processes for pre-clinical solid oral dosage forms.
- Collaborate with cross-functional teams within DPT (e.g., Synthetic Enabling Technologies, Pivotal Synthetic Drug Product) and external functions (e.g., Drug Substance Technologies, Attribute Sciences, Supply Chain, and Contract Manufacturing) to support drug product development.
**Key Responsibilities:**
- Develop and leverage platform capabilities, independently coordinate and analyze results, and communicate findings effectively in team meetings to drive formulation and process decisions.
- Generate, collect, and document all relevant data accurately in electronic laboratory notebooks (e-LNs) to ensure compliance and traceability.
- Maintain current knowledge of GMP regulations and SOPs, ensuring all activities adhere to regulatory and operational standards.
- Provide scientific and risk-based evaluations of complex processes and product quality data, developing patient-centric strategies that balance business needs and innovative solutions.
**What You'll Need:**
- Bachelor's degree (BS), Associate's degree (AA/AS), or High School diploma.
- Five (5) years of GMP experience
- Hands-on experience in small molecules and oral solid dosage forms.
- Solid understanding of oral solid dosage forms, such as granulation, roller compaction, drying, milling, blending, compression, film coating, etc.
- Basic coding experience in R and/or Python is required to analyze and visualize experimental data, along with familiarity with at least one statistical software package like JMP or Minitab.
- Strong oral and written communication skills are also essential for effectively collaborating with team members, management, and external contacts.
**Salary Range:** $95,000 - $110,000 per year, depending on experience.
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