Job Title: Process Development Associate
Location: Thousand Oaks, CA (Onsite)
Job Summary:
- The Process Development Associate will be an integral part of our Drug Product Technologies (DPT) department. This role is primarily responsible for executing small molecule formulation experiments to support the development of oral solid dosage forms for early-stage clinical studies. The successful candidate will have the opportunity to contribute significantly to the creation and optimization of digital platform capabilities, which are crucial to our operations.
Key Responsibilities:
- Conducting small molecule formulation experiments to aid in the development of oral solid dosage forms for early-stage clinical studies.
- Contributing to the creation and optimization of digital platform capabilities to enhance operational efficiency and effectiveness.
- Collaborating with cross-functional teams within the DPT department and external functions to support drug product development.
- Generating, collecting, and documenting all relevant data accurately in electronic laboratory notebooks (e-LNs) to ensure compliance and traceability.
- Maintaining current knowledge of Good Manufacturing Practices (GMP) regulations and Standard Operating Procedures (SOPs), ensuring all activities adhere to regulatory and operational standards.
- Assisting with the maintenance and upkeep of the formulations laboratory, ensuring operational readiness and compliance with safety standards.
Required Skills and Qualifications:
- A minimum of five years of experience in a GMP environment and a solid understanding of unit operations for oral solid dosage forms.
- Basic coding experience in R and/or Python for analyzing and visualizing experimental data.
- Familiarity with at least one statistical software package like JMP or Minitab.
- Strong oral and written communication skills for effective collaboration with team members, management, and external contacts.
- Relevant BS with 0+ years of experience, AS with 2+ years of experience, or HS with 4+ years of experience.
- Foundational knowledge of technical principles, theories, and concepts to perform routine work in a role.
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy