Director of Pharmaceutical Development

3 weeks ago

Larne, United Kingdom Millicent Pharma NI Full time
Job Title: Director of Pharmaceutical Development

Join Millicent Pharma NI as a Director of Pharmaceutical Development and lead the pharmaceutical development activities to ensure the development of robust pharmaceutical products.

Key Responsibilities:
  • Direct the development (analytical and formulation) and manufacture of pharmaceutical drug products, devices, and drug product-device combination products.
  • Direct the development and validation of analytical methods for the testing of active ingredients, excipients, packaging materials, drug products, devices, and drug product-device combination products.
  • Consistent with FDA standards, direct the process validation of to-be commercial drug products, devices, and drug product-device combination products.
  • Direct the technical transfer of commercial manufacturing and analytical testing of drug products, devices, and drug product-device combination products.
  • Stay current with emerging technology and regulatory guidance within industry.
  • Ensure effective partnership with other areas in the Company including Operations, Quality, Regulatory, Clinical and Pharmacovigilance.
  • Support the preparation and maintenance of the Pharmaceutical Development & Pharmaceutical Technology budget.
  • Represent Technical Operations in internal and external (vendor) meetings and teleconferences in a positive, collaborative manner.
  • Responsible for ensuring that training and development programs for staff members are in place to meet future objectives of the business.
  • Participates in Talent Management, succession planning, and talent acquisition.
Requirements:
  • Education: Degree in pharmacy, chemistry, or engineering.
  • Experience: 5 yrs experience working within the pharmaceutical development and/or technical operations department of a pharmaceutical company.
  • 2 yrs experience at a managerial level.
  • Specialist knowledge: Experience of developing new Drug Products. Knowledge of ICH regulations. Experience of developing drug/device combination products. Experience in the validation of drug product manufacturing processes.
  • Special skills and dispositions: Excellent interpersonal and leadership skills. Ability to be flexible and adaptable to change. Pro-active and self-motivated with a high level of initiative and persistence. Demonstratable ability to set and meet targets. Experience within a multidisciplinary team, interacting with Regulatory Authorities, drafting Regulatory eCTDS and INDs (module 3). Demonstratable ability to communicate fluently in English, both orally and in writing.
Location:

Be available to attend place of work Larne, UK. Be amenable to work-related travel, as required.

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