Career Opportunities

Product Development and Commercialization Specialist

Department

CMC and Manufacturing

Employment Type

Full Time

Position Summary

Iterum Therapeutics are a clinical-stage pharmaceutical company dedicated to developing significantly differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant (MDR) pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world.

Reporting to the Director of Drug Product, the Product Development and Commercialization Specialist is responsible for drug product development, technology transfer and scale up activities for all drug products in Iterum's portfolio. This includes activities in both parenteral (sterile) and solid oral dose clinical supply and the development and registration programs related to commercial manufacturing.

Essential Functions:

• Ensure production and supply of parenteral and oral solid dose drug products for clinical and preclinical studies from CMOs.
• Manage drug product contractors and suppliers; e.g., selection, contracting, management, timelines and cost control.
• Use scientific and Quality by Design (QbD) principles to identify and implement process development studies.
• Develop and establish drug product control strategies and execute registration batches in support of regulatory submissions.
• Provide technical support and guidance to CMOs during product development, registration and PPQ execution.
• Provide manufacturing technology expertise and drive drug product commercial process development at contract manufacturing organisations.
• Partner with Quality to review deviation reports, risk assessments, and CAPA's; and ensure drug product compliance.
• Prepare drug product sections of INDs, IMPDs and other regulatory submissions.
• Oversee pre-formulation studies for next generation product including drug characterisation and excipient selection
• Design and manage drug product formulation development studies of solid oral and parenteral dosage forms.
• Provide technical input to equipment CQV activities at third party vendors

Required Skills and Experience:

• Minimum 5 years of experience working in process development, technology transfer, validation or related technical environment.
• Experience with GMP/ICH regulations and guidelines
• Experience managing third party relationships and contracts is preferred
• Experience with new product introductions, particularly in oral solid dose formulations is essential.
• Experience preparing or supporting FDA/EMA regulatory dossiers
• Ability to diagnose issues, solve problems and provide solutions
• Demonstrated leadership abilities with excellent project management, negotiation and interpersonal skills and ability to work to strict deadlines
• Strong verbal and written communication skills
• Computer proficiency in Word, Excel, MS Project
• Self-starter with the ability to work effectively and independently
• Ability to work well in small teams and with other cultures
• Willingness to travel 25% required (including international)

PREFERRED EDUCATION, SKILLS AND EXPERIENCE:

• B.Sc degree in a relevant scientific discipline is desired, M.Sc is preferred

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