Manufacturing Operations

Manufacturing Operations - Senior Specialist, Industrialization Thursday, September 5, 2024
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We are seeking to hire a Senior Specialist , Industrialization to join our Industrialization teamat Italian sites.
If any of the below describes you, we would love to meet you
Summary
Reporting directly to the Senior Manager, Industrialization - Italy, the Senior Specialist, Industrialization supports industrialization department activities by providing her/his technical expertise and collaborating with relevant business units (e.g. R&D, Manufacturing, Quality, Regulatory, Business Development) during scale-up, process validation, technology transfer, implementation of manufacturing processes and life cycle management of existing products. This Senior Specialist works in an effective and cooperative manner under deadlines and in respects of Company policies, procedures and regulations.
Responsibilities:
Carries out his/her work in compliance with company procedures and in accordance with the provisions of the Occupational Health and Safety Management System and Good Manufacturing Practices.
Assesses technical feasibility, calculates cost of goods, prepares capital investments and capacity analyses of commercial products and Technology transfer opportunities.
Collaborates with Business Support Team, Industrialization Manager and involved business units providing all the information needed to prepare commercial proposals.
Works with Pharmaceutical Development (R&D) to scale-up and validate new products from lab to industrial scale and is accountable for industrial scale registration batches.
Contributes to Life Cycle Management of existing commercial products, including recurrent manufacturing process validation activities, process improvement and optimization.
Is accountable with Industrialization Team for the Manufacturing Process Validation Plan, writes protocols and reports, and provides technical assistance to Operations and Quality during the manufacturing process validation runs.
Identifies quality improvement and cost reduction opportunities.
Provides technical support and project management to add new sources of API, excipients, and packaging components.
Provides technical support to Operational Excellence team, as needed.
Participates in the development and implementation of methods, procedures and regulations necessary for the smooth flow of business.
Respects policies, procedures, and regulations in force in the company.
Completes assigned tasks in a safe manner and in a constant state of alertness.
Upholds Company policies, including the Ethics and Conduct Code.
Works in a cooperative manner with managers, supervisors, coworkers, customers and the public.
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 is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES
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