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Head of Research Manufacturing
Location: On-site (Hatfield, PA) 
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We are looking for a motivated, flexible, and experienced individual to join our team and lead Research Manufacturing. The primary role of the Head (Manager/Director) of Research Manufacturing is to work with the Research team to develop and prepare a variety of genetic payloads (DNA and RNA), as well as targeting molecules, to be used in combination with the company’s proprietary 3DNA platform for in vitro and in vivo testing. The right individual will work collaboratively with the R&D team, as well as the Technical Development team, to transfer the technical details and processes between groups in preparation for scale-up and CMC of the drug candidates. Additionally, the individual leading these efforts should have experience developing drugs through non-clinical and clinical stages.

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Responsibilities

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

  • Manage an interdisciplinary team to develop and prepare therapeutic payloads and cellular targeting strategies in combination with our patented DNA scaffold technology

  • Establish timelines for the preparation, characterization, and quality assessment of materials prepared by the Research Manufacturing Team

  • Adapt various purification methodologies and biochemistry/molecular biology techniques to yield high purity, functional genetic payloads and targeting molecules

  • Develop research and analytical methods to assess functionality and durability of genetic payloads and targeting molecules

  • Divide time between both laboratory work, study design and data analysis

  • Oversee lead the execution of in vitro assays characterizing the output of the research manufacturing process to demonstrate reproducibility of manufacturing, purity of material, and process rigor

  • Design and test protocols for transfer to the CROs, CDMOs, and Development team

  • Maintain data acquisition and analysis in electronic laboratory notebook

  • Design experiments, analyze data, troubleshoot, author study protocols, and maintain detailed records for technical documents

  • Lead and manage cross-functional team, including training junior laboratory personnel on a variety of skills and methods

  • Present scientific data at internal and external meetings/conferences

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Education and Experience 

  • PhD in Molecular Biology, Biochemistry, or similar field with 7+ years of industry experience or MS with 10+ years of industry experience

  • Detail and timeline oriented with strong organizational and communication skills

  • Self-starter and ability to work independently and multitask in a highly entrepreneurial environment

  • Hands-on experience with nucleic acid and other biomolecule purification techniques including affinity, SEC and AEX chromatography, and methods routinely used to purify plasmids, small and large RNA and DNA molecules and protein/peptide oligo conjugates

  • Experience with in vitro assay development including HPLC separation and characterization assays, gel electrophoresis, gene and protein expression including Western analysis, qPCR, qRT-PCR, ELISA, and cell-based functionality testing

  • Experience in molecular cloning and a basic understanding of plasmid/vector characterization

  • Experience with biomolecule conjugation chemistries and methods

  • Experience with the preparation and characterization of research grade materials used in non-clinical testing in vitro and in vivo

  • Experience using an ATKA FPLC, semi-prep HPLC, and other scalable purification methods

  • Ability to troubleshoot and adapt existing methods or develop new methods to improve the output of current processes

  • Experience managing a team of cross-functional scientists

  • 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

  • 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

 

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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