Downstream Manufacturing Specialist

3 days ago


Fremont, California, United States Asahi Kasei America Inc Full time
Job Title: Downstream Manufacturing Associate

We are seeking a highly motivated and detail-oriented Downstream Manufacturing Associate to join our team at Bionova Scientific LLC. As a key member of our Purification/Manufacturing group, you will be responsible for executing complex unit operations, troubleshooting equipment, and supporting GMP readiness and manufacturing activities.

Key Responsibilities:
  • Execute complex unit operations, including chromatography, TFF, depth filtration, virus filtration, and buffer preparation in GMP manufacturing suites.
  • Maintain own training within compliance and adhere to established regulations and cGMP.
  • Support equipment troubleshooting, pilot scale material generation, non-GMP tox material generation, and GMP downstream manufacturing activities.
  • Author and review technical documents, such as tech transfer protocols and reports, production batch records, training materials, manufacturing SOPs, and regulatory filing documents.
  • Contribute to quality activities, such as investigations and area walk-throughs, and support authoring deviations, CAPA, and change control.
Requirements:
  • BS in Life Sciences or related discipline with 0-1 years of relevant experience or combination of experience and relevant advanced degree.
  • Working knowledge of cGMP compliance and industry-standard purification processes and equipment.
  • Experience with process monitoring software and equipment software.
  • Creative thinker with ability to identify better and more efficient methods to address issues and gaps.
  • Ability to work independently and on cross-functional teams.
What We Offer:
  • Competitive compensation range: $25-$30 per hour.
  • Health benefits at a subsidized rate.
  • Life insurance and disability program.
  • Retirement plan (401K) with up to 8% employer match.
  • Paid time off and holidays.

We are an equal opportunity employer and believe a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.



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