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Head of Manufacturing

1 month ago

Humble, United States RadioMedix Inc Full time
About the job
The Head of Manufacturing will be responsible for overseeing production, process development, and validation activities related to radiotheranostic APIs and drug products (Ge/Ga-68 generator production, Ga-68-PSMA11). This dynamic role will involve assisting other operators during off days with day-to-day activities. The individual in this position will also be responsible for operator trainings, media fills, and aseptic manufacturing assessments alongside the subject matter expert (SME) on site. It is necessary to be willing to work with radioactive materials and to follow RAM safety rules and procedures. Familiarity with cGMP manufacturing practices is preferred.

About Us
RadioMedix Inc., a biotechnology company located in Humble, Texas, is looking for an experienced Head of Manufacturing Operations to work at its newly constructed GMP radiopharmaceutical manufacturing facility.

Responsibilities:
  • Provide day-to-day leadership and management of RadioMedix manufacturing Operations within our CDMO and product development for our internal projects.
  • Responsible for driving the organization to achieve and surpass organizational productivity goals and meeting all quality and regulatory requirements.
  • Provide leadership in the development of continuous performance improvement systems to ensure the achievement of business goals.
  • Responsible for the measurement and effectiveness of internal processes.
  • Oversee and drive the product development process, including but not limited to, contributing to FDA filings, regulatory pathway strategy, and drug process development.
  • Interface with other members of the Executive Leadership team to support the development and regulatory pathways of novel drug candidates.
  • Provide timely, accurate, and complete reports on the operating condition of the company to the Board of Directors, CEO, and Executive Leadership.
  • Collaborate with the Executive Leadership to develop and implement plans for the operational infrastructure of systems, processes, and personnel designed to accommodate the strategic objectives of the organization.
  • Interface with clients as needed to provide executive leadership support and represent the Company at all relevant conferences, trade shows, and industry panels as needed.
  • Select and maintain qualified personnel in all positions who report directly to the Head of Manufacturing Operations.
  • Foster a success-oriented and accountable environment within the organization by goal setting and assessments regularly.
  • Maintain a constant physical presence within the facility (onsite role) to effectively oversee operations.

Education and Qualifications:
  • Minimum BSc (or equivalent) in engineering (chemical) or bioprocessing specialization.
  • Minimum of 10 years' leadership experience, particularly in CGMP operations, preferably in a CDMO or Pharmaceutical company. Radiopharmaceutical experience a plus.
  • Skilled in organizational development, personnel management, and budget and resource development.
  • Knowledge of the drug approval process, and experience overseeing or working on the team tasked with gaining FDA approval of both branded and generic products.
  • Experience managing a services business (CDMO)
  • Excellent people skills, with the ability to partner with an Executive Leadership team.
  • Able to navigate interpersonal communication and compose clear and professional written business correspondence.
  • Possess personal qualities of integrity, credibility, and commitment to the organization's mission, vision, and values.
  • Flexible and able to multitask and work in a complex and fast-moving environment, while also driving toward solutions.
  • Demonstrated resourcefulness in setting priorities and guiding investment in people and systems.
Residency Requirement:
  • Employees must permanently reside and work in the State of Texas.