Responsibilities:

• Plan and execute studies to support microbial (bacteria and yeast) process understanding and characterization to improve process robustness and production yield.
• Guide risk assessment and mitigation strategy development.
• Execute laboratory experimentation using homogenizers, centrifugation, chromatography systems (AKTA), and cross flow filtration systems.
• Understand analytical methods used to quantify and monitor plasmids and recombinant proteins for in-process control and release.
• Prepare and oversee buffer development and production.
• Develop and implement protocols and procedures that embody 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 cleanroom in accordance with cGMP procedures and policies (including gowning into classified area).
• Ensure the process development laboratory is cleaned daily and that labware are routinely sanitized and stored properly.
• Perform change over cleaning in the cGMP suites.
• Interact with clients.

• Requirements:

Bachelors in Life Sciences, Chemical or Biochemical Engineering, or other related Biological Science degree.

• Experience in development of pDNA and recombinant products in microbial platform for cGMP manufacturing.
• Minimum 2 years of experience in biopharmaceutical industry.
• Previous work in process development and characterization in microbial based products.
• Deep knowledge in statistical methodologies and DoE for process development and optimization.
• Experience in scaling up activities.
• Experience with use of single use equipment (preferred).
• Ability to work after hours and on weekends, when required.
• Strong interpersonal, communication (verbal and written), and organizational skills.
• Hands on experience in Downstream operations, such as column packing, TFF set up and execution, Chromatography system set up and execution.
• Experience with AKTA/Unicorn Systems (Explorer, Avant, Pilot).
• Experience with Repligen and/or Sartorius crossflow filtration systems.
• Experience with Design Expert or/and JUMP software.
• Ability to interpretate analytical results to be applied to process optimization and robustness.
• Comfort working in fluid structure of a start-up biotech.
• Independence and creative problem-solving abilities.
• Ability to handle highly confidential business information.
• Have the flexibility to work in different shifts including night and weekends.
• Ability to lift to 30 kg.
• Exceptional time management and multi-tasking skills.
• Team leadership skills and team player.

EOE/DFW