Scientist Assay Development

Technical Development Research Scientist: Assay Development

We are seeking trailblazers, motivated to deliver innovative solutions, who are enthusiastic collaborators, driven by a sense of urgency to assist patients.

Code Biotherapeutics is a privately-held biotechnology company pioneering the development of genetic medicines to treat and potentially cure serious and life-threatening genetic diseases. Code Bio leverages its proprietary, novel multivalent synthetic DNA delivery platform, 3DNA®, which has been engineered to overcome many of the challenges inherent with viral-based gene therapies such as immunogenicity, gene of interest size and delivery limitations, ability to re-dose, and vector manufacturing complexity. The Company is advancing an internal pipeline focused on select diseases without a cure as well as establishing partnerships to take forward programs in both rare and prevalent diseases.

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. Your expertise is required to develop a variety of assay formats, with a focus on both PCR- and cell-based methodologies, to 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.

Key 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 PCR- and cell-based assays to accurately determine purity, content, and function of 3DNA intermediates and therapeutic candidates.

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

Work with our 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 electronic laboratory notebooks 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.

Basic Qualifications:

• A BS in Biochemistry, Biology, Molecular Biology, Chemistry 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
• PCR assay development: endpoint and qPCR/dPCR (SYBR Green, Taqman)
• Plasmid DNA restriction enzyme analysis
• Demonstrated experience with cell-based assay development, with a focus on characterization of function (i.e., potency), with skills including:
• Cell culture of commercially available cell lines and primary cells
• Cell banking
• Familiarity with a variety of biochemical and biophysical assay readouts (e.g., ELISA, IHC, FACS, PCR, chemi-/bioluminescence, SPR, BLI, fluorescence anisotropy, etc.)
• Sound writing and documentation skills; ability to perform data analysis using Excel, Minitab or JMP
• Detail-oriented with strong organizational and communication skills
• Ability to work independently and multitask in a highly entrepreneurial environment

Preferred Skills/Experience (in addition to the above):

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

• Demonstrated experience with HPLC assay development: RP-, IEX-, and SEC-HPLC, and/or other chromatography formats
• Demonstrated experience with FFF-MALS
• Demonstrated experience with the characterization of macromolecular binding interactions by BLI/SPR
• Demonstrated experience with ELISA development and troubleshooting
• Familiarity with the characterization of macromolecules by mass spectrometry, including but not limited to LC-MS and ESI

Demonstrated experience with GMP testing, including analytical method qualification and/or validation experience

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

Familiarity with Design of Experiments (DOE)

Code Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Code Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

In addition, Code Bio is committed to social responsibility and developing an inclusive culture. Much like the development of our novel delivery of genetic medicines, we believe that our work requires the creativity and ingenuity of a diverse workforce, and we are committed to pursuing that in all facets of the work experience at Code Bio. We will continue to educate ourselves about the inequities and barriers present in our society and act as a company where we can make a difference.

Code Bio is proud to be an Equal Opportunity Employer.

Benefits:

At Code Bio we believe in investing in our team. Our compensation & benefits programs are just one of the many ways we strive to help our employees take care of themselves and their families. We offer a variety of programs, from comprehensive medical insurance to generous time off policies designed to help meet the needs of our diverse team.

Benefits include:

· Competitive base salary and annual incentive opportunities

· Equity participation

· Comprehensive health and welfare benefits (including medical, dental, vision, life, disability, and accident insurance)

· Wellness and recognition programs

· Paid time off and holidays, including a week off at the end of the year to re-charge

·Environment where professional development is actively encouraged and supported.