Senior Scientist Process Development
At Abzena, you will have the opportunity to work in a dynamic and rewarding work environment. The scientists’ at Abzena conduct research on the cutting edge of science and deliver meaningful results in the pharmaceutical industry. The Chemistry and GMP Manufacturing group at Abzena has an opening for a Senior Scientist to conduct process development/optimization research and cGMP production on small molecule and ADC linker-payload targets. We are looking for a synthetic organic process development scientist to join our team with the ability to design, troubleshoot and optimize the synthesis and process development of small molecules and ADC linker-payload targets. The candidate must demonstrate the ability to independently develop safe and efficient synthetic processes that can be scaled-up, reliably and reproducibly, while adhering to EHS, quality and regulatory guidelines.
- Ph. D. with 3+ years relevant experience or M.S. degree in Chemistry with 6+ years of relevant industry experience. Position level/grade commensurate with experience.
- The ability to independently design and conduct process development and optimization research.
- Comprehensive understanding mechanistic principles of organic chemistry.
- Experience with producing master batch records, specifications, standard operating procedures, specific work instructions and other aspects of QA documentation and compliance.
- General knowledge of ICH and FDA guidelines for the synthesis and production of drug substance.
- Thorough knowledge and experience of analytical techniques, compound characterization and purification.
- Hands-on experience using analytical, semi-preparative and preparative normal and reverse phase purification techniques.
- Refined presentation skills.
- Experience in handling High Potency-Active Pharmaceutical Ingredient on R&D and production scale.
- Experience working in a cGMP environment with the ability for detailed record-keeping, data analysis and chain of custody controls required in the successful implementation of cGMP framework.
- Understanding of the essentials of operating and maintaining cGMP facility.
- Experience with PAT, crystallization, flow chemistry, peptide synthesis, oligonucleotides and oligosaccharides.
- Work with cGMP Analytical to support analytical method development for cGMP manufacturing.
- Act as the representative between Chemistry and the Quality Group for authoring, reviewing, and approving documentation.
- Participate in pre- and post-GMP campaign operations such as drafting campaign reports, cleaning of facility and equipment.
- Prepare appropriate campaign specific documentation and be responsible for procuring chemicals and supplies.