615531
Our client, a leading Pharmaceutical company in Thousand Oaks, CA, is looking for a Process Development Senior Associate to be responsible for executing small molecule formulation experiments to support the development of oral solid dosage forms for early-stage clinical studies.
Required Skills:
- 0+ Years w/ Relevant BS OR equivalent 2+ Years w/ Relevant AS OR equivalent 4+ Years w/ HS
- Understanding of typical unit operations for the manufacture of oral solid dosage forms, such as granulation, roller compaction, drying, milling, blending, compression, and film coating.
- Experience with programming languages such as R and/or Python, with the ability to analyze and visualize experimental data, and familiarity with at least one statistical software package (e.g., JMP, Minitab).
Responsibilities:
- 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.
- 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.
- Assist with the maintenance and upkeep of the formulations laboratory, ensuring operational readiness and compliance with safety standards.
- Lead the creation and optimization of digital platform capabilities to streamline drug product development processes, ensuring efficient and effective formulation outcomes.
- Deliver clear and consistent progress reports to management and cross-functional teams, keeping all stakeholders informed on project status, future plans, and program needs.
***Compensation within this range will be commensurate with level of experience***
