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Senior Manager - Quality

Senior Manager – Quality

Novome is building genetically engineered microbial medicines (GEMMs) that perform defined activities in the human gut to treat chronic diseases. We have developed the first platform for controlled colonization of the gut with engineered therapeutic bacteria and are applying this to multiple disease areas as well as expanding our platform capabilities. We are moving our lead program in secondary hyperoxaluria into Phase 2 clinical trials, and are actively progressing programs in IBS, IBD, and Immuno-oncology.

We are currently seeking an experienced professional to serve as a Senior Manager in CMC Quality. The person in this role will be responsible for managing all aspects of quality oversight and work with the manufacturing, regulatory, and clinical teams to implement and execute quality deliverables. The person will have significant experience with assay development and qualifications, generation of Standard Operating Procedures (SOP), batch record analysis, Out of Specification (OOS) and investigations, root cause analysis and Corrective and Preventative Actions (CAPA), release testing, disposition, etc. In addition, the Sr. Manager will have experience in working with Contract Development and Manufacturing Organizations (CDMO), technology transfers, partner audits, and facilities documentation.

The Sr. Manager will serve as a liaison between Novome and the CDMOs, enabling the delivery of drug product to support current and future clinical trials. This person will have a multi-faceted skillset and will be a strong individual contributor, while also having the experience to oversee a diverse team at the CDMO.

Responsibilities

  • Interface with teams across multiple CDMOs to ensure on-time manufacturing, release testing, and delivery of high-quality drug product
  • Partner with external quality teams, and quality assurance/regulatory consultants
  • Review, interpret, and approve analytical methods, SOPs, reports, investigations, and other technical documents
  • Develop, transfer, and qualify routine and novel analytical methods
  • Review and author study reports, batch records, IND sections, and other necessary documents
  • Operate with a phase-appropriate cGMP mindset
  • Interact with regulatory agencies and conduct CDMO partner audits, potential travel to partners
  • Engage in technology development to enable current and future process improvements

Key Qualifications

  • BS with 8+ years or MS with 5+ years of industry experience
  • Degree in chemical engineering, engineering, bioengineering, biochemistry, molecular biology, or a related discipline
  • Experience in cell/gene therapies, live therapeutics, or microbiome therapeutics is highly desirable
  • Deep understanding of analytical methods qualification, transfer, and/or validation
  • Current knowledge in regulatory environments, CFR, ICH, and USP guidelines
  • Experience in conducting audits, FMEA, and identifying quality risks
  • Ability to identify and implement continuous improvement opportunities
  • Strong communication skills and the ability work with external partners
  • Open to remote

To apply, please visit https://novomebiotechnologies.applytojob.com/apply/

Novome Biotechnologies, Inc. is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

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