Genprex
Manufacturing

Senior Director of Manufacturing Operations and Sciences

Remote or Austin, Texas

OVERVIEW

Reporting directly to the Chief Operating Officer and building/managing a team of manufacturing, supply chain, process development and logistics staff, the Senior Director Manufacturing Operations and Sciences (MOS) will provide leadership and direction for the company’s manufacturing, formulation optimization, and analytical development programs supporting the Genprex clinical development programs. Together with Genprex clinical and quality teams, the Senior Director Manufacturing Operations and Sciences will be responsible for management and oversight of the company’s CRO’s. The MOS lead will have the option of working remotely or from the Company’s offices in Austin, Texas.

JOB RESPONSIBILITIES

  • Lead Genprex CMC strategy for clinical trial Drug Products
  • Serve as the company’s main point of manufacturing expertise, contributing as a technical subject matter expert
  • Lead formulation optimization of existing and new products
  • Oversee analytical development and testing project plans for Drug Substance/Drug Product release
  • Work closely with CMOs used to produce and release GMP material:
    • Lead CMC cross-functional work with Genprex vendors
    • Conduct site visits and communication
    • Oversee stage-appropriate analytical development and validation activities to enable characterization, and testing of clinical trial
    • Monitor scope, milestones, dependencies, timelines and costs
    • Coordinate the resolution of issues due to process variability, product out of limit or out of specification findings
    • Manage short and long-term project commitments to supply of drug substance and drug product and communicate levels to internal project teams
  • Coordinate key vendor and supplier evaluations, particularly those supplying services related to raw material supply, product manufacturing, release, storage, and characterization
    Assist with sponsored research programs with academic institutions
    Ensure completion of study protocols and study reports pertaining to process improvements, qualifications, validations, and process implementation
  • Assure completion of CMC-related content and documentation for FDA submissions

QUALIFICATIONS

  • BS in chemistry, biology, engineering, or a related discipline. MS or PhD preferred
  • Experience overseeing both process engineering and analytical development in partnership with CMOs
  • 8+ years’ experience in developing and managing FDA-regulated clinical GMP manufacturing.
  • 5+ years’ management experience in the biopharma industry
  • Experience in contributing to CMC sections of an IND or BLA
  • Formulation experience highly desirable
  • Experience in oversight of transfer and implementation of CMC activities at CDMO’s and partner facilities
  • Knowledge of cGMP / ICH compliance regulations for manufacturing
  • Experience negotiating and overseeing contract manufacturers is critical
  • Proven track record of leadership in analytical development
  • Must be a self-starter who thrives in an entrepreneurial environment
  • Highly organized, detail oriented, results driven and accountable for his/her team
  • Effective verbal and written communication skills, including high emotional intelligence
  • Willingness to travel

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