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Lead Automation Specialist

2 months ago

California, United States Astrix Full time

Astrix is a leading, research-oriented pharmaceutical organization dedicated to developing innovative treatment solutions for unmet medical needs. We are seeking a Lead Automation Specialist to enhance our team. This role presents a unique opportunity to contribute to groundbreaking therapies and positively impact patient care.

Job Type: 1 year contract

Location: Alameda County, CA

Compensation: $55-$60/hr.

Key Responsibilities:

  • Oversee the implementation of new methodologies within GMP environments for both internal and external projects.
  • Provide expert advice on intricate challenges and act as the technical authority for large-scale production processes, including cell culture, bioreactors, centrifugation, chromatography, and filtration.
  • Facilitate process transfers, product introductions, and initial supply phases, ensuring adherence to GMP and regulatory requirements.
  • Serve as the technical intermediary between production and clients, delivering strategic insights, technical direction, and mentorship to junior personnel. Manage process troubleshooting and ongoing enhancements.
  • Plan and conduct evaluations for medium to high complexity initiatives, ensuring alignment with manufacturing protocols and regulations.
  • Develop and maintain comprehensive technical documentation, encompassing process outlines, performance evaluations, and technical components of regulatory submissions.
  • Analyze and monitor large-scale manufacturing workflows, creating data repositories and visualizations for effective analysis and reporting.
  • Contribute to the design and planning of small-scale studies to facilitate process transfers and enhancements.

Skills and Qualifications:

  • Bachelor's degree in engineering, Life Sciences, or a related discipline.
  • 5-10 years of experience in biopharmaceutical production, with a focus on process engineering and technical oversight.
  • Familiarity with manufacturing processes, mixing, pharmaceutical production, and contract manufacturing.
  • Strong knowledge of upstream and downstream processes, aseptic processing, and GMP production.
  • Experience in regulatory submissions, technical documentation, and project management.
  • Exceptional communication abilities and experience in cross-functional, high-pressure settings.
  • Demonstrated capability to plan, execute, and manage projects autonomously, with robust problem-solving and analytical skills.