Scientist III - Purification Process Development (Oligonucleotides/Peptides)

SGS Consulting; Boston (MA); On-site; USD 75,000 - 120,000; Full time

Job summary

SGS Consulting is seeking an Associate Scientist to develop and characterize purification processes for a growing pipeline of oligonucleotide and peptide therapies. You will use various chromatography modes and UF/DF, learn chemical steps, and explore new technologies to enhance purity and productivity.

The role requires documenting work, mentoring staff, and leading pilot-scale activities, with opportunities for tech transfer to GMP facilities and participation in IND regulatory sections.

Qualifications

• Proven track record of planning and executing projects and experiments.
• Demonstrated ability to document laboratory work in development reports, and to mentor others.
• Experience with protein, peptide or DNA/RNA purification using Ion Exchange, Hydrophobic Interaction, or Reversed-Phase chromatography.
• UF/DF experience for scalable processes.
• Strong organizational, communication, and time management skills.
• Ability to work independently and in cross-functional teams.

Responsibilities

• Develop and characterize purification processes for oligonucleotides and peptide drug therapies.
• Use chromatography, ultrafiltration, and learn cleavage/conjugation/hybridization steps.
• Investigate new purification technologies to improve purity, robustness, and productivity.
• Collaborate cross-functionally to improve process understanding and manage activities.
• Document laboratory work in development reports.
• Train and mentor new employees.
• Lead pilot scale activities and scale-up to GMP facilities.
• Participate in tech transfer and regulatory sections for INDs.
• Conduct purification development including process characterization and scale-up.
• Contribute to tech transfer documentation, manufacturing support, and troubleshooting.
• Carry out robustness studies and early/late-stage characterization.
• Serve as SME for purification and coordinate with Research, Manufacturing, and tech transfer teams.
• Write development reports and lead small initiatives.
• Perform independent root cause investigations with supervisor guidance.

Skills

Project planning & execution

Written & verbal communication

Purification tech development

Chromatography knowledge

UF/DF experience

Protein/peptide/DNA/RNA analysis

AKTA/Unicorn experience

DoE statistical methods

Team collaboration

Education

Bachelor’s in Biochemistry/Chemical Eng/Chemistry or life sciences

Master’s degree (optional)

Industry experience 2–4 years (Assoc Scientist 3/Engineer 2)

US work authorization (citizen/green card)

Tools

AKTA purification systems

Unicorn software

Job description

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 ReversedPhase.
• 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, ormaster’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’sdegree with 2 years industry experience, is required.
• Must be a U.S. citizen, permanent resident, or green card holder.