Process Development Scientist, Downstream
Location: Bristol, PA
The Bioconjugation Process Development and Manufacturing department in Bristol, PA is seeking a highly motivated scientist to join their bioconjugation downstream process team to support Abzena Bristol’s expanding process development and cGMP manufacturing operations.
The bioconjugation team focuses on developing downstream conjugation bioprocesses to manufacture antibody-drug conjugates and conjugate vaccines. The successful candidate will work in a highly collaborative and fast-paced environment, and will be directly involved in the development, optimization, scale-up of bioconjugation processes and cGMP manufacture of protein-drug conjugates. This includes the hands-on execution of chromatographic purifications (affinity, hydrophobic interaction, and ion exchange chromatography), and membrane filtrations (Normal and tangential flow filtrations). As well as authoring of relevant documentation (process development reports, batch records, and SOPs), and perform in-process bioanalytical characterization (HPLC, UPLC, LC-MS, MALDI, MALS, etc.) of bioproducts.
Required Experience and Skills
- Experience in preparative purification of biological molecules (antibodies, carrier proteins, viruses, viral vectors, or other biological molecules).
- Experience in normal flow filtrations and tangential flow filtrations (UF/DF).
- Experience with cGMP manufacturing operations and GxP principles.
Preferred Experience and Skills
- Direct hands-on experience with medium to large-scale preparative chromatography systems (AKTA Pilot, AKTA Ready, etc.), and manual or automated TFF skids.
- Experience with quantitative determination of scalable process parameters for normal flow filtrations, tangential flow filtrations, and preparative chromatographic separations.
- Direct on-the-floor cGMP manufacturing experience for biotherapeutics.
- Understanding of common bioconjugation reactions and approaches.
- Experience with basic bioanalytical techniques (HPLC, LC-MS, UV-spectrophotometry, etc.)
- Experience with large scale bioprocess equipment: pallet tanks, pumps, biowelders, biosealers, bio-rockers, single-use assemblies.
- Minimum of BS degree with 3 years of experience, or MS degree with 1 year of experience, in Biological sciences or Bio-engineering.
- Ability to stand for extended periods of time, and lift heavy objects.
- Less than 10% of occasional weekend work may be required.