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Senior Upstream Process Development Specialist

Astrix
Middlesex, NJ Full Time
POSTED ON 4/17/2025
AVAILABLE BEFORE 5/11/2025

About Astrix

  • Astrix is a global biopharma company with a strong presence in R&D and manufacturing.

Job Description

  • This role offers an exciting opportunity to work closely with our team of experienced professionals in upstream manufacturing.

Responsibilities

  1. Design, execute, analyze, and document all phases of process development for upstream batch processes.
  2. Work collaboratively with manufacturing associates and engineers to ensure timely execution of engineering and clinical batches.
  3. Perform cell culture and bioreactor operations across various scales, including single-use fed-batch bioreactors.
  4. Develop equipment specifications and optimize manufacturing techniques to improve efficiency and quality.
  5. Leverage data analytics tools to collect and analyze operational data, making real-time adjustments to products, instruments, and equipment.
  6. Ensure compliance with GMP standards and environmental health and safety regulations.

Requirements

  • Bachelor's or Master's degree in Chemical, Biological, or Biochemical Sciences, with at least 3 years of relevant experience in the biopharmaceutical industry.
  • Strong foundational knowledge and subject matter expertise in executing both engineering and clinical batches.
  • Familiarity with single-use manufacturing consumables and aseptic manufacturing environments.
  • Proven ability to work independently and collaboratively within a team; excellent interpersonal skills.
  • Strong verbal and written communication skills, with advanced computer and organizational abilities.

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