Principal Engineer, API & Drug Substance Process Development
HQ- Cambridge, MA /
CMC & Quality /
Salaried, full-time
/ Hybrid
Arbor is seeking a motivated, creative, and experienced Process Engineer to establish and support protein and mRNA process development, optimization, scale-up, and technology transfer. The successful candidate will play a leading role in the implementation of internal process development capabilities and assist in the development of robust and scalable processes to support various programs at external vendors. The candidate will use innovative approaches to understand the critical process parameters and the impact on the quality attributes and stability of the drug substance. The ideal candidate will be proactive, enthusiastic, collaborative, and with a desire to establish a scientific/engineering-driven approach to enable manufacturing solutions for a variety of gene editing API/DS.
Key Responsibilities
- Lead the implementation and development of robust and scalable processes for the production of protein and nucleic acid-based drug substances and APIs at external CDMOs
- Drive process development, optimization, and troubleshooting, and establish control strategies to support protein and mRNA production, formulation, and stability
- Implement control strategies to support
- Support PD and manufacturing activities at CDMOs including attending regular technical/project calls and participating in person-in-plant activities
- Act as SME on CMC team and use technical expertise to drive sound decision making
- Perform data analysis and interpretation, communicate conclusions and provide sound recommendations to multidisciplinary teams
- Technical review of manufacturing process documents
- Write protocols, technical reports, and SOPs to support process development, manufacturing activities, and regulatory filings as applicable
- Review and author CMC sections of regulatory submissions
Preferred Qualifications
- PhD in Chemistry, Chemical Engineering, Biomedical Engineering or related discipline; 3+ years of industry experience. Master’s degree with 5+ years of industry experience. Strong background in bioprocess development of biologics, vaccines, and/or gene therapy.
- Experience with mRNA process development is required
- Protein production and purification and/or synthetic RNA experience preferred
- Proficient with cell-free reactions, mixing, UF/DF, and chromatography purification
- Experience (either hands-on, or interpreting data) with analytical characterization techniques such as HPLC/UPLC, TEM, DLS, UV-Vis, and fluorescence spectrophotometry required
- Knowledge of complex manufacturing process engineering solutions and willingness to drive innovation to solve technical challenges
- Familiarity with statistical design of experiments (DoE) and analysis, and quality by design frameworks desired
- Strong organizational skills and ability to deal with complex problem-solving flexibility to adjust to changing priorities, and willingness to mentor junior scientists.
- Highly self-motivated, driven, can-do, make-it-happen attitude with the ability to own and drive projects
- Strong collaborator with cross-functional teams and external partners
- Capable of continuous learning, open-minded, curious, highly organized and detail-oriented
Our Values:
Our values govern the work we do at Arbor, and we’re hoping that they resonate as strongly with you as they do with us!
· Purposeful Action: Start with The Why
· Bold Resilience: Adopt a Growth Mindset
· Humble Authenticity: Start in the Heart
About Arbor:
At Arbor, we are discovering, developing and making available to all patients the next-generation of genetic medicines. We are disrupting the field through our proprietary discovery engine to develop a portfolio of differentiated genetic editing and delivery capabilities. We have an unencumbered portfolio of multiple CRISPR based genetic modifiers that can be tailored to correct the underlying pathology of each genetic disease. Our pipeline of genetic medicines will focus on bringing cures to all patients with genetic disease.
We seek highly-motivated individuals with the dedication, integrity, and creative spirit needed to thrive in an innovative company. Working at Arbor offers a unique opportunity that combines the fast pace and growth opportunities of a startup with the intellectual rigor and creativity of academia. Our salaries are competitive, our benefits are generous, and our team is exceptional.
We promote diversity and inclusion not just in our recruitment processes, but in everything we do. We’re an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive, positive, and free of discrimination and respecting of all backgrounds and beliefs.
