Location (mandatory): Cambridge, MA 02142 (On-site) We are seeking a highly motivated and creative individual with some process development experience to join our Oligonucleotide/Peptide Purification Development team. This position provides an exciting opportunity to develop robust, high purity, state of the art processes for the purification of oligonucleotides and gain hands-on experience and exposure to the design and development of manufacturing processes for clinical and commercial therapeutics. The individual will contribute to developing new cutting-edge technologies in oligonucleotide and peptide purification.
Job Responsibilities:
Develop and characterize purification processes for a rapidly expanding pipeline of new oligonucleotides and peptide drug therapies. Utilize multiple modes of chromatography and ultrafiltration and learn chemical cleavage/conjugation/hybridization steps. Investigate new purification technologies that seek to enhance purity, process robustness and/or productivity of existing oligonucleotide platform processes. Collaborate cross-functionally with other groups to improve process understanding and manage team activities. Document laboratory work in development reports. Train and mentor new employees. Lead pilot scale activities. Scale-up and technology transfer of oligonucleotide processes into pilot and GMP manufacturing facilities. Participate in writing regulatory sections for INDs. Perform purification development including process development, process characterization, and scale-up for chromatography, detritylation, and UF/DF unit operations. Contribute to tech transfer activities, document review, manufacturing floor support, and troubleshooting. Conduct early- and late-stage process characterization and robustness studies. Act as a subject matter expert on purification processes and facilitate interactions within the oligonucleotide organization and cross-functionally with Research, Manufacturing, MS project, and tech transfer teams. Write development reports and lead small, focused initiatives. Conduct independent work such as root cause investigations and evaluation of processes with guidance from the supervisor
Skills:
Proven record of successfully planning and executing projects and experiments. Excellent verbal and written communication skills. Demonstrated technical proficiency and creativity in developing innovative technologies/approaches in purification. Excellent organizational, communication, and time management skills. Lab experience in purification of proteins, peptides and/or DNA/RNA using column chromatography, including Ion Exchange, Hydrophobic Interaction, and/or Reversed Phase. Experience with ultrafiltration/diafiltration (UF/DF). Hands-on experience in analysis of proteins, peptides or DNA/RNA, preferably using both HPLC and UV/Vis spectroscopy. Experience using AKTA purification systems and Unicorn software is a plus. Experience using statistical Design of Experiments (DoE) is a plus. Experience in statistical analysis is a plus. Ability to work and communicate both individually and within teams.
Education/Experience:
Associate Scientist 3/Engineer 2: Bachelor's degree in Biochemistry, Chemical Engineering, Chemistry, or related life science field with 2-4 years industry experience, or master's degree with 0-2 years of industry experience, is required.
Senior Associate Scientist:
Bachelor's degree in Biochemistry, Chemical Engineering, Chemistry, or related life science field with 4 years industry experience, or master's degree with 2 years industry experience, is required. Must be a U.S. citizen, permanent resident, or green card holder.