Research and Development Scientist

1 day ago


SaintBauzilledePutois, Occitanie, United States Akron Bio Full time

About the Role:

A Research and Development Scientist position is available at Akron Bio, focusing on microbial process development and characterization for cGMP manufacturing. The successful candidate will have a strong background in Life Sciences, Chemical or Biochemical Engineering, or related Biological Science degree.

Key Responsibilities:

  • Plan and execute studies to support microbial process understanding and characterization, improving process robustness and production yield.
  • Develop risk assessment and mitigation strategies.
  • Conduct laboratory experimentation using homogenizers, centrifugation, chromatography systems (AKTA), and cross-flow filtration systems.
  • Understand analytical methods for quantifying and monitoring plasmids and recombinant proteins in-process control and release.
  • Prepare and oversee buffer development and production.
  • Develop and implement protocols and procedures embodying best practices in biologics manufacturing (cGMP, QbD).
  • Serve as a technical expert at bench/pilot scale and assist with technology transfer from process development to cGMP manufacturing, including definition of bill of materials, sample plan, batch record drafting/review, and discrepancy resolution.
  • Write and review documentation, such as SOPs, process development protocols, investigations, development reports, cGMP production batch records, and work instructions.
  • Support production of plasmids and proteins in cGMP cleanrooms in accordance with cGMP procedures and policies (including gowning into classified areas).
  • Maintain the process development laboratory cleanliness and ensure labware are sanitized and stored properly.
  • Perform change-over cleaning in the cGMP suites.
  • Interact with clients and stakeholders effectively.

Requirements and Qualifications:

  • Bachelor's degree in Life Sciences, Chemical or Biochemical Engineering, or other related Biological Science field.
  • Minimum 2 years of experience in the biopharmaceutical industry, preferably in microbial process development.
  • Previous experience in downstream operations, such as column packing, TFF setup and execution, and chromatography system setup and execution.
  • Strong knowledge of statistical methodologies and DoE for process development and optimization.
  • Experience with single-use equipment and scaling up activities.
  • Proficiency in Design Expert or JUMP software and AKTA/Unicorn Systems (Explorer, Avant, Pilot).
  • Ability to interpret analytical results for process optimization and robustness.
  • Team leadership skills and ability to handle confidential business information.

Salary Information:

The estimated salary range for this position is between $80,000 - $110,000 per annum, depending on qualifications and experience.

About Akron Bio:

Akron Bio is a dynamic biotech company committed to innovation and excellence in microbial process development and cGMP manufacturing. Our team thrives in a fast-paced environment, prioritizing quality, safety, and customer satisfaction.



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