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Join Us

Analytical Development Scientist (Technical Development)
Location: On-site (Hatfield, PA) 
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In this role you will be a part of our dynamic Technical Development (TD) team focused on non-viral therapies using our novel DNA scaffold technology.  This will require you to develop a variety of chromatography and molecular biology assays and perform characterization studies on our 3DNA scaffolds and constructs.  You will partner with our internal R&D team and external collaborators to design, develop and qualify assays to measure critical quality attributes of our products and intermediates.

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Responsibilities

The primary responsibilities of this position include, but are not limited to:

  • Work independently and as part of an interdisciplinary team to develop assays, characterize process intermediates and test conjugated drug substances based on the company’s novel DNA scaffold technology.

  • Develop chromatography- and molecular biology-based assays to accurately determine purity, content, size, structure and function of our intermediates and therapeutic candidates.

  • Characterize targeting and payload molecules including peptides, proteins, and oligonucleotide conjugates.

  • Work with R&D team and development partners to adapt and refine various assays to support phase-appropriate technical development studies.

  • Maintain data records and analysis in ELN records and perform data analysis, including basic statistics, to evaluate method performance.

  • Draft method development reports, test method SOPs and characterization reports.

  • Maintain laboratory equipment and perform limited troubleshooting as needed.

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Education and Experience 

  • BS in Biochemistry, Chemistry, Biology, or equivalent degree with a minimum of 5 years of assay development experience in a pharmaceutical industry setting, or an MS with a minimum of 2 years of industry experience

  • Demonstrated experience working with nucleic acids including, but not limited to:

  • PCR assay development: endpoint, quantitative, and digital format(s)

  • Plasmid DNA expression, purification, and restriction enzyme analysis

  • In vitro RNA transcription and quantification

  • Hybridization assay development

  • Demonstrated experience with HPLC assay development: RP-HPLC, SEC-HPLC, IEX, and/or other chromatography formats

  • Familiarity with ELISA assay development and troubleshooting

  • Familiarity with the characterization of macromolecular binding interactions by SPR, BLI, and/or ELISA

  • Sound writing and documentation skills. Ability to perform data analysis using Excel, Minitab or JMP

  • Well-versed in ICH guidelines such as Analytical Validation (Q2), Analytical Procedure Development (Q14), Stability (Q1A), etc.

  • Detail-oriented with strong organizational skills

  • Ability to work independently and multitask in a highly entrepreneurial environment

  • Flexible and comfortable with a fast-paced and evolving business environment

  • Excellent communication skills

  • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and functions, leads by example

  • Responsive, can-do attitude

  •  Preferred Skills/Experience

    • PhD in Biochemistry, Chemistry, Biology, or equivalent degree with demonstrated biochemical/biophysical assay development experience

    • Demonstrated experience with the development of chromatography-based assays specific to nucleic acids analysis

    • Method qualification and validation experience

    • Experience with the purification of macromolecules by FPLC, e.g., Äkta Explorer/Avant

    • Experience with chemical conjugation techniques

    • Experience with mammalian cell culture

    • Familiarity with Six Sigma and Design of Experiments (DOE)

 

We offer a competitive salary and benefit package, including an employer matched 401k. Code Bio is proud to be an Equal Opportunity Employer.

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Interested individuals should send a cover letter and CV to careers@codebiotx.com or:

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