- Company 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.
location: Newbury Park, California
job type: Contract
salary: $24.00 - 26.63 per hour
work hours: 9 to 5
education: Bachelors
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.
qualifications:
- Bachelors degree OR Associates degree and 2 years of experience OR High school diploma / GED and 4 years of experience
- 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 AI scripting (e.g., ChatGPT, Copilot).
- Excellent oral and written communication skills to communicate with the team, peers, management, and external contacts.
skills: R Language, SOP Development, Good Manufacturing Practices (GMP)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
