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Senior BioProcess Engineer

Blaine and Associates, Inc. El Segundo, CA
  • Expired: over a month ago. Applications are no longer accepted.

We are seeking a Senior BioProcess Engineer for our rapidly growing biologics company. You will be responsible for the development and scale up of internal manufacturing processes to support the growth and development of our regenerative medical products. You will work closely with Development, Regulatory, Quality Control, internal and outsourced Manufacturing, to develop and scale processes, equipment and packaging of all products.

Responsibilities:

  • Ensure appropriate equipment and processes are used for internal manufacturing
  • Implement and oversee purity, sterility, and equipment to support scale up
  • Identify and implement appropriate shipping packaging for products
  • Support development of systems for equipment calibration, certification and qualification to ensure compliance
  • Assist with the development of manufacturing metrics, data collection, reporting, and process improvements
  • Stay current with industry standards, new trends, and all applicable regulations
  • Compile reports on costs and inventory levels
  • Review and communicate production status reports
  • Serve as point of contact between production and planning teams

Qualifications:

  • 10+ years in biopharmaceutical/biotech manufacturing engineering/development
  • Degree in Biomedical Engineering, Chemical Engineering, or similar related field
  • Experience in scaling up/out manufacturing to GMP processes and systems to develop biopharmaceutical development
  • Experience in cell based therapies, development of biologics, and the systems, testing, validations required to support FDA BLA license requirements
  • Excellent written and verbal communication skills
  • Ability to work well in teams

Blaine and Associates, Inc.

Why Work Here?

This is a "career changer" position. if you are ready for the change, this is the job for you!

Blaine and Associates, Inc. is a boutique search firm specializing in Management, Accounting, Real Estate, Human Resources, Marketing, Administrative and Legal positions.

Address

El Segundo
El Segundo, CA
USA