What are the responsibilities and job description for the Manager, Analytical Operations position at Oligo Factory?
Oligo Factory, Inc. Background
Founded in 2006 by oligo synthesis technology experts, Oligo Factory delivers high-quality custom DNA and RNA oligos at scale to pharmaceutical, diagnostics and life science customers with a focus on customer responsiveness and satisfaction.
In 2023, Oligo Factory’s Holliston, MA facility achieved ISO 13485:2016 certification and ICH Q7 compliance, marking a significant milestone in our dedication to quality systems that support our customers oligonucleotide demands.
We continue to invest in technology and people to serve the growing demands of scientific discoveries. Our third-generation synthesis platform (NANDA Series) enhances turn-around-time, control and quality.
Oligo Factory products and services are built to serve all the DNA/RNA synthesis markets and applications, from synthetic biology to qPCR to functional genomics and therapeutics.
The Manager, Analytical Operations will own the development and execution of existing and new analytical methods for custom oligonucleotides in a cGMP environment. This includes determining the proper chemistry for the analysis and development of new buffer systems and gradients for both HPLC and LC/MS analysis. When not working on a cGMP project, the analytical chemist will also support daily activities in the purification lab.
Location: Holliston, MA, USA
Number of Employees: 15
Direct Reports: None
Reports to: Director of Manufacturing Operations. Will work closely with Synthesis Operations, Purification Operations, R&D, as well as the Director of Quality Assurance.
Essential Functions & Responsibilities
→ Develop a rigorous program of analytical methods, including but not limited to H/UPLC and LC/MS and execute daily manufacturing operations analytics.
→ Assist, as needed, in the purification and downstream processing of custom oligonucleotides, including quantification via UV Vis, HPLC purification, and ultrafiltration.
→ Prep samples for HPLC and LC/MS analysis to support Manufacturing Operations and R&D teams.
→ Implement and integrate customer developed methods into the Purification Lab’s analytical systems.
→ Follow and maintain Quality System documentation.
Position Requirements & Ideal Experience
→ Bachelor’s degree in Chemistry, Biochemistry, Biology, or other relevant discipline. Master’s of Science preferred.
→ 4 years of experience in developing analytical methods for oligonucleotides (H/UPLC, LC/MS)
→ 4 years of experience in the development and interpretation of LC/MS analyses
→ Familiarity with the Waters suite of purification and analytical instrumentation, as well as the Waters software suite (Empower, MassLynx, waters_connect, and NuGenesis)
→ 2 years of experience in both analytical and preparative scale liquid chromatography
→ Previous specific experience in nucleic acid technologies & tools and/or CMO/CDMO companies strongly preferred, with previous experience in the analysis of oligo libraries desirable.
→ Motivated to lead, collaborate and work in a fast-paced, customer-centric start up culture.
→ Proficient in Google Workplace and Microsoft Office tools (.doc, .xls, .ppt).