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.
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
