Scientist III - Purification Process Development (Oligonucleotides/Peptides)

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.