Biotechnology Engineer

4 weeks ago

Thousand Oaks, California, United States BioSpace, Inc. Full time
Job Details

At BioSpace, Inc., we are dedicated to improving the quality of life for people around the world. We are seeking an experienced Biotechnology Engineer to join our team in the Drug Substance Technology Engineering department. The successful candidate will support technology transfer and process validation for human therapeutic products across the clinical and commercial manufacturing space.

Responsibilities:
  • Transfer cell culture/purification drug substance processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites.
  • Provide process validation support for late stage commercial processes.
  • Provide on-the-floor technical support for successful scale-up and transfer of process technology, and for clinical or commercial manufacturing operations.
  • Provide routine process monitoring and troubleshooting.
  • Perform data trending and statistical process analysis.
  • Provide technical contributions for process related deviations (NCs), CAPAs and change controls.
  • Identify and support process related operational excellence opportunities.
  • Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory.

Requirements:
  • High school diploma / GED and 8 years of Process Development experience OR
  • Associates degree and 6 years of Process Development experience OR
  • Bachelors degree and 2 years of Process Development experience OR
  • Masters degree

Preferred Qualifications:
  • Masters degree in Chemical/Biochemical Engineering or related subject area.
  • 3 + years of experience in Process Engineering related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP).
  • Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance.
  • Experience working in/supporting a commercial cGMP manufacturing facility.
  • A firm understanding of cell culture process and related equipment; scale-up from bench to commercial scale, mass oxygen transfer capabilities, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes.
  • Knowledge of aseptic processing/techniques, harvest and clarification processes used in mammalian cell culture processes AND/OR a good understanding of purification process and associated equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations.
  • Process development (PD) experience supporting cGMP manufacturing at large scale.
  • Strong capability in scientific/engineering/laboratory analysis, troubleshooting and ability to apply sophisticated problem resolution abilities.
  • Ability to develop and follow detailed protocols.
  • Independently motivated with ability to multi-task and work in teams.
  • Excellent written and verbal communication with experience with technical writing and presentations.

About Us:
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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