Process Development Associate

3 weeks ago

Thousand Oaks, United States Randstad Life Sciences US Full time

Immediate opportunity for two (2) Process Development Associates to work with the Pre-Pivotal Oral & Enabling Delivery team at one of the world's leading biotechnnology companies located in Thousand Oaks, CA.


Schedule/Shift: 1st shift, Mon.-Fri.

Position type: 2 year contract (through December 2026); extension possible


Job Summary: In this role, you will be a key member of the Oral and Enabling Delivery Systems group within the Drug Product Technologies (DPT) department.


Essential Duties and Responsibilities:

  • 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.
  • 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.
  • Employee Value Proposition:
  • This role offers the opportunity to work on innovative oral solid dosage forms for early-stage clinical studies, contribute to cutting-edge digital platforms, and collaborate with cross-functional teams. It's ideal for candidates seeking to expand their expertise in a dynamic and impactful environment at a leading biotech company.


Qualifications:

  • Bachelor's degree (BS), Associate's degree (AA/AS), or High School diploma.
  • Five (5) years of GMP experience
  • Hands-on experience in small molecules and oral solid dosage forms.
  • Solid understanding of oral solid dosage forms, such as granulation, roller compaction, drying, milling, blending, compression, film coating, etc.
  • 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.

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