CMO MS&T Specialist

Pharmathen

Μαρούσι, Αττικής
Μόνιμη
Πλήρης Απασχόληση

Πριν 26 ημέρες
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Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a MS&T (Manufacturing, Science & Technology) Specialist for the Supply Chain /CMOs department at our Marousi premises.As a MS&T Specialist the ideal candidate will be responsible for technology and manufacturing process support from the delivery to CMOs to the launch through routine commercial phase and even beyond, for every product in the CMO network. He/ She will serve as the link between the labs and the production lines and support operations with activities such as continuous improvement, implementation of new technologies and products, scale-up and troubleshooting.More particularly:RequirementsWhat you will do:

Facilitate supply, technical, quality issues in response to unexpected events on a daily and ad hoc basis (assess, review, contribute to resolve, monitor and implement action plan)
Participate actively and/or lead OOT, OOE, OOS events resolution and deviation management support
Be the key technical leader at the CMO, assuring that current and upcoming manufacturing processes are robust and efficient. Manage the overall Technical Transfer program at the CMO and ensure effective technical input regarding equipment and materials are provided on time in the TT process
Oversee the ‘end to end’ technical success of process transfers and new product launches, integrate technical stewardship with manufacturing activities effectively and prioritize, while remaining compliant with any current regulations
Oversee technical process support activities, leading to successful, on time resolution of investigations and improvement of the manufacturing processes. This includes site activities for optimization of new and existing manufacturing processes, while championing and leveraging the robustness program
Be accountable for the identification of best practices in the CMO industry related to technology transfers and process support to manufacturing. Achieve effective introduction of best practices to the CMO and the network to enable a competitive advantage
Represent MS&T Third Party Operations internally and externally to the organization
Drive effective working relationships with CMOs and internal functions in the organization, such as Quality, Operations, Engineering, Regulatory Affairs, R&D. Promote a collaborative and inclusive environment while driving a culture of high performance and mutual accountability
Lead, motivate, mentor and develop team members of Third-Party Operations to meet or exceed TPO, company goals and objectives

The ideal candidate should have:

Bachelor/Master in Life sciences or Engineering (Chemistry, Pharmacy, Chemical Engineering, or a related pharmaceutical science)
At least 7 years of combined experience in the Pharmaceutical Industry in the areas of Manufacturing Operations, Quality Assurance, Quality Control, R&D

Job-Specific Skills:

Experience in OSD, Injectables, Ophthalmic and combination products
Experience in product and process development and commercialization in a global environment
Experience in Technology Transfer & devices (combination products), scale up and technology evaluation
Experience in finished product development and commercialization, process engineering, aseptic processing, fill, finish, inspection, and packaging operations
Extensive knowledge of Quality Systems, Validation Principles for product and manufacturing processes, engineering design and process control fundamentals in commercial manufacturing
Strong understanding of project management systems and tools
Ability to analyze data and information to resolve complex problems/issues as required
Solid understanding of the current federal, local and international regulations regarding the production, testing, and release of finished products
In-depth understanding of cGMPs, industry and regulatory standards and guidelines
Exceptional communication and interpersonal skills, with the ability to influence and build relationships with internal and external stakeholders
Excellent communication in English language (writing & speaking)
Technology savvy
Ability to multitask, prioritize, and manage time efficiently

BenefitsWhat you'll gain:

Involvement in a high-caliber, team-oriented and dynamic atmosphere
Exposure to challenging business issues and practices
Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.

Pharmathen