Manufacturing Operations Specialist

21 ore fa

Roma, Lazio, Italia Adare Pharma Solutions A tempo pieno
Senior Specialist, Industrialization

Adare Pharma Solutions is seeking a highly skilled Senior Specialist, Industrialization to join our Industrialization team at our Italian sites. As a key member of our team, you will play a critical role in supporting industrialization department activities and collaborating with relevant business units to drive process validation, technology transfer, and manufacturing process validation.

Key Responsibilities:
  • Carry out work in compliance with company procedures and Good Manufacturing Practices.
  • Assess technical feasibility, calculate cost of goods, and prepare capital investments and capacity analyses of commercial products and technology transfer opportunities.
  • Collaborate with Business Support Team, Industrialization Manager, and involved business units to prepare commercial proposals.
  • Work with Pharmaceutical Development (R&D) to scale-up and validate new products from lab to industrial scale and be accountable for industrial scale registration batches.
  • Contribute to Life Cycle Management of existing commercial products, including recurrent manufacturing process validation activities, process improvement, and optimization.
  • Be accountable with Industrialization Team for the Manufacturing Process Validation Plan, write protocols and reports, and provide technical assistance to Operations and Quality during manufacturing process validation runs.
  • Identify quality improvement and cost reduction opportunities.
  • Provide technical support and project management to add new sources of API, excipients, and packaging components.
  • Provide technical support to Operational Excellence team, as needed.
  • Participate in the development and implementation of methods, procedures, and regulations necessary for the smooth flow of business.
Requirements:
  • BS/BA degree in Health Science (e.g., Pharmaceutical Technology, Chemistry, Biology) from a five-year accredited university or college; plus 5 years of related experience required.
  • Full Proficiency in Italian (main language) and in English.
  • Strong know-how of technology transfer projects, especially for oral solid dosage forms.
  • Extensive knowledge of pharmaceutical technologies.
  • Excellent interpersonal, written, and oral communication skills.
  • Proficient in Microsoft Office, including advanced skills in Excel.
  • Ability to coordinate, contribute to, and work within a cross-functional team.
  • Ability to thrive in a dynamic and fast-paced environment.
  • Ability to prioritize duties and manage multiple projects with minimal supervision.
  • Exceptional attention to detail and excellent organizational skills.
  • Ability to accommodate up to 15% travel.

Adare Pharma Solutions is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital, and veteran status.

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