Ideal candidate: Candidate should have at least five years of GMP experience and a solid understanding of unit operations for oral solid dosage forms, such as granulation, roller compaction, drying, milling, blending, compression, and film coating. 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.
Client is seeking an enthusiastic, motivated, and team-oriented Process Development Senior Associate at our Thousand Oaks, CA headquarters to join the Pre-Pivotal Drug Product Technologies organization. In this role, you will be a key member of the Oral and Enabling Delivery Systems group within the Drug Product Technologies (DPT) department. 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. Additionally, 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.
Basic Qualifications
0+ Years w/ Relevant BS OR equivalent 2+ Years w/ Relevant AS OR equivalent 4+ Years w/ HS Foundational knowledge of technical principles, theories, and concepts to perform routine work in a role
Top 3 Must Have Skill Sets:
1. 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.
2. 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).
3. Excellent oral and written communication skills to communicate with the team, peers, management, and external contacts.
Day to Day Responsibilities:
1. 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.
2. Develop and leverage platform capabilities, independently coordinate and analyze results, and communicate findings effectively in team meetings to drive formulation and process decisions.
3. Generate, collect, and document all relevant data accurately in electronic laboratory notebooks (e-LNs) to ensure compliance and traceability.
4. Maintain current knowledge of GMP regulations and SOPs, ensuring all activities adhere to regulatory and operational standards.
5. Provide scientific and risk-based evaluations of complex processes and product quality data, developing patient-centric strategies that balance business needs and innovative solutions.
6. Assist with the maintenance and upkeep of the formulations laboratory, ensuring operational readiness and compliance with safety standards.
7. Lead the creation and optimization of digital platform capabilities to streamline drug product development processes, ensuring efficient and effective formulation outcomes.
8. Deliver clear and consistent progress reports to management and cross-functional teams, keeping all stakeholders informed on project status, future plans, and program needs.
Red Flags:
Lack of Experience with Oral Solid Dosage Forms
No Programming Experience
NO Statistical Software Knowledge
Poor Communication
No Experience in GMP Compliance
history of short job tenures
