Scientist III – Purification Process Development (Oligonucleotides/Peptides)

sgs-job-5908

Scientific
 Massachusetts
Oligonucleotide purification
peptide purification
process development
process characterization
scale-up
chromatography
detritylation
UF/DF
HPLC
UV/Vis spectroscopy
AKTA purification systems
Unicorn software
Design of Experiments (DoE)
statistical analysis
technology transfer
manufacturing process development
root cause investigations
CMC documentation
IND regulatory support

Contract - 06 Months

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.

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