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Job Title: Process Development Senior Associate
Location: Thousand Oaks, CA (Onsite)
Duration: 24 Months
Role Overview:
Seeking a motivated and team-oriented Process Development Senior Associate to join the Pre-Pivotal Drug Product Technologies (DPT) organization. This role is part of the Oral and Enabling Delivery Systems group and focuses on executing formulation experiments to support the development of oral solid dosage forms for early-stage clinical studies. The ideal candidate will contribute to both hands-on formulation development and digital platform optimization, supporting the design and advancement of drug product processes.
Key Responsibilities:
Execute formulation experiments for oral solid dosage forms (OSD) supporting early-stage development.
Collaborate with cross-functional teams including Drug Substance Technologies, Supply Chain, and Contract Manufacturing.
Analyze experimental data and communicate findings to drive formulation and process decisions.
Document all activities in electronic laboratory notebooks (eLNs) ensuring compliance and traceability.
Ensure adherence to GMP regulations, SOPs, and quality standards.
Perform risk-based assessments of processes and product quality data.
Support laboratory operations, maintenance, and safety compliance.
Develop and optimize digital platforms to enhance drug product development workflows.
Provide regular updates and progress reports to stakeholders and management.
Basic Qualifications:
Top Required Skills:
Strong understanding of oral solid dosage manufacturing processes (granulation, roller compaction, drying, milling, blending, compression, coating).
Experience with data analysis tools such as R or Python, including visualization and basic AI scripting (e.g., ChatGPT, Copilot).
Excellent communication skills (written and verbal) with the ability to present technical data clearly.
Interview Requirement:
Candidates are required to prepare a 20-30 minute presentation on a relevant topic (e.g., formulation development, GMP manufacturing), covering:
Approach and relevant project experience
Key insights and learnings
Challenges faced and how they were resolved
Why Join:
Opportunity to gain hands-on experience with cutting-edge drug product development
Exposure to cross-functional collaboration and innovative technologies
Strong learning environment with potential for skill development in both formulation science and digital platforms
Additional Notes:
Position open due to increased team workload
No extension guaranteed
Resume quality, relevance, and stability will be key evaluation factors
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Spectraforce Technologies
May 05, 2026