Senior Specialist, Quality Assurance Operations

enGene • Boston, MA

7h • $115,000 - $135,000

About The Position

enGene (NASDAQ: ENGN) is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead product candidate, detalimogene voraplasmid, is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive to BCG. Detalimogene voraplasmid was developed using enGene’s PROPRIETARY, Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit enGene.com . Role enGene is seeking a self-motivated and versatile individual to join us as Senior Specialist QA Operations within the Quality organization. This is a key role focused on Quality oversight of enGene’s external manufacturing partners (CDMO), including management and oversight of production, product disposition activities and Quality Systems/ event management. The candidate will work closely with enGene’s CMC operations, Quality Control, and Regulatory team members. This role is critical in maintaining a strong partnership with enGene’s CDMO in pursuit of advancing our pipeline and is expected to be hands-on in the technical and operational details of the Quality Assurance operations at external manufacturing sites.

Requirements

• Expert knowledge of FDA and ICH regulatory guidance and regulation specific to GMP product manufacturing and disposition.
• Thorough knowledge of current Good Manufacturing Practices and deep understanding of aseptic processing guidelines as they relate to the production of gene therapy products for clinical trials.
• Proficiency in MS Office suite
• Effective team working skills with cross-functional teams.
• Skilled in influencing and escalating within a matrixed organization to drive decisions.
• Bachelor's or Master’s degree in a scientific discipline
• A minimum of 7 years of related QA experience in pharmaceuticals or biologics.
• Strong understanding of GMP disposition processes for clinical and commercial drug substance and drug product for US and ROW

Nice To Haves

• Experience with multi-region (US, EU, ROW) commercial Quality preferred.
• Experience with biologics and/or gene therapies is preferred
• Experience working with CDMO or experience working at a biologics CDMO preferred

Responsibilities

• Perform batch record review and facility issue resolution with GMP partner sites (CDMO).
• Conduct final disposition of clinical and commercial drug product, ensuring that disposition is conducted in compliance with applicable regulations and requirements. Includes coordination with QPs as required.
• Manage processes for demonstrated quality oversight of GMP partner sites, including partner investigations, CAPA and change controls. Identify and communicate quality and compliance risks to senior quality management and participate in determination of appropriate plan to address such risks.
• Support GMP inspections and audits at company’s GMP partner sites.
• Support the development and maintenance of procedures and quality systems for GMP operations.
• Support compilation of quality performance and compliance metrices as relates to product disposition and GMP partner site operations.
• Responsible for providing operational support for key quality systems (e.g. risk management, complaints, document management, training, and change control).
• Trend metrics related to non-conformances/CAPAS, training compliance at partner sites along with product disposition metrics.
• Represent quality input at internal cross functional and CDMO meetings.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level