Process Development Associate

Payrate: $22.00 - $24.00/hr
 
Summary:
We are seeking an enthusiastic, motivated, and team-oriented Process Development Associate at our Thousand Oaks, CA 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 and clinical solid oral dosage forms.
 
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.

 
Top 3 Must Have Skills:

• Understanding of typical unit operations for the manufacture of oral solid dosage forms, including granulation, roller compaction, drying, milling, blending, compression, and film coating. Knowledge of solubility-enabling formulation approaches for oral drug products would be desirable.
• Understanding of analytical and solid-state characterization such as DSC, HPLC, UV, PXRD as well as characterization of pharmaceutical materials and dosage forms, including density, friability, disintegration, dissolution, and flowability.
• Excellent oral and written communication skills with the ability to communicate effectively with team members, peers, management, and external partners.

 
Pay Transparency: The typical base pay for this role across the U.S. is: $22.00 - $24.00/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 

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