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Process Development Leader
Location: On-site (Hatfield, PA) 

The primary role of the Process Development Leader is to design, conduct and oversee team activities to support the development of unit operations for Code Biotherapeutics’ innovative gene delivery technology and product pipeline. This includes downstream process development, scale-up & tech transfer activities and working with external vendors. As part of the Technical Development team, you will work closely with team members in Research Production, Analytical Methods Development and R&D.

Responsibilities

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

  • Lead projects and manage a small team of scientists/engineers

  • Design and execute studies to support the development of a robust and scalable 3DNA synthesis process

  • Manage and/or execute experimental studies to support downstream process development, optimization, and characterization (including chromatography, photo crosslinking and/or TFF)

  • Author and review documents including development reports, SOPs, tech transfer protocols/reports and CMC sections of regulatory filings

  • Analyze and interpret experimental results and present them at cross-functional meetings

  • Build process understanding to support technology transfer to internal or external groups for manufacturing at pilot, engineering, clinical, or commercial scales

  • Apply best practices and concepts of process development and purification to Code’s innovative platforms and disruptive technologies

  • Support material generation for research and toxicology studies as needed

  • Participate in the expansion of internal process development capabilities

  • Interact with external CMO/CDMOs, vendors, and partners and assist in technology transfer

  • Collaborate effectively with other functions in Technical Development, Research and Program Management to advance projects and programs

Education and Experience 
  • BS in Chemical Engineering, Biochemistry, Biology, or related discipline with 10+ years of industry experience or a MS with 7+ years of industry experience or a PhD with 4+ years of industry experience including management or supervisory experience

  • Significant experience with purification techniques such as chromatography and/ or tangential flow filtration

  • Practical experience with chromatography and other process equipment is required, ideally with lab, pilot, and large-scale systems

  • Experience with statistical and/or DoE principles and relevant statistical software (Minitab, JMP) to guide process optimization

  • Sound knowledge of GMPs

  • Experience with nucleic acids and/or gene therapy preferred

  • Highly motivated, ethical, and professional self-starter with strong interpersonal skills and a quality and sense of urgency mindset, who is capable of influence and negotiation with stakeholders to successfully prosecute the completion of projects per timeline

  • Demonstrated motivational leadership leading teams with an ability to articulate vision and successfully drive execution

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

  • Strong organizational skills and attention to details

  • 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

  • Excellent MS Office skills with a specific focus on word, excel and power point applications to author technical reports and presentations

  • Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities

 

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

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

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