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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 challenging diseases and conditions. 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 outcomes.

Job Type: 1 year contract

Location: Alameda County, CA

Compensation: $55-$60/hr.

Core Responsibilities:

  • Oversee the implementation of novel processes within GMP environments for both internal and external products.
  • Provide expert advice on intricate challenges and act as the technical authority for large-scale production, including cell culture, bioreactors, centrifugation, chromatography, and filtration.
  • Facilitate process transfers, product introductions, and initial supply, ensuring adherence to GMP and regulatory requirements.
  • Serve as the technical intermediary between production and clients, delivering strategic guidance, technical expertise, and mentorship to junior personnel. Supervise process troubleshooting and ongoing enhancements.
  • Plan and carry out evaluations for medium to high complexity initiatives, ensuring alignment with manufacturing standards and regulations.
  • Develop and sustain comprehensive technical documentation, encompassing process descriptions, performance summaries, and technical components of regulatory submissions.
  • Monitor and analyze large-scale manufacturing operations, creating data repositories and visualizations for effective analysis and reporting.
  • Contribute to the design and planning of small-scale studies to support process transfers and enhancements.

Required Skills and Qualifications:

  • Bachelor's degree in engineering, Life Sciences, or a related discipline.
  • 5-10 years of experience in biopharmaceutical production, emphasizing process engineering and technical leadership.
  • Familiarity with manufacturing processes, mixing, pharmaceutical production, and contract manufacturing.
  • Strong knowledge of upstream and downstream processes, aseptic processing, and GMP manufacturing.
  • 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 strong analytical and problem-solving skills.