Global Manufacturing Science and Technology API Senior Process Specialist
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Manufacturing Science & Technology
Are you an experienced process specialist, with a data driven mindset? And are you looking to help shape the future of a rapidly developing pharmaceutical company with global operations
The GMS&T API team is a global team, located in Copenhagen, with a focus to bring our API production sites closer together and ensure implementation of best practice processes and procedures.
In this position, you will be an integral part of Xellia Pharmaceuticals’ Global Manufacturing Science and Technology (GMS&T) API team, where you will manage standardization activities and support tech transfers both typically with a high degree of cross-functional involvement. In addition, you will serve as general specialist for API process performance and issues.
You will be involved in multiple aspects of “cross site activities” in our global API production network, and required to coordinate activities with our many partners in e.g. local MS&T, R&D, production, regulatory affairs, quality and engineering.
Main delivery
⦁ Partner with other MS&T teams to develop, review and implement Xellia’ s global standards, guidelines and SOPs ensuring best practice procedures across Xellia API sites.
⦁ Manage standardization of best practice procedures across sites.
⦁ Ensure knowledge sharing of process improvements and product / process issues across all Xellia API production sites
Other tasks
⦁ Support project aspects to ensure a robust and timely implementation of new API products or processes either through tech transfers from R&D or between sites.
⦁ Support R&D scientists with production scale experience during development phase through commercial scale-up and implementation
⦁ Act as global oversight during tech transfer between separate API sites
⦁ Propose and support API technological improvement initiatives (e.g. continuous improvements, CI) in the commercial phase of the product lifecycle
⦁ Serve as scientific and technical representative for API process-related issues at Xellia API sites as well as third party API manufacturing sites
- Partner with site MS&T and other relevant stakeholders to routinely evaluate process performance to ensure all Xellia API products are sufficiently monitored and maintain satisfactory process capabilities.
- Support local MS&T to resolve complex reduction in capability or performance.
- Ensure knowledge sharing of process improvements and product / process issues across all Xellia API production sites
Join a global function and grow
Although you will have our production facility in Copenhagen as main base you will collaborate closely with your colleagues across Xellia´ s other manufacturing and business locations, which will likely involve some traveling.
You will be able to deliver tangible results with high impact by coordinating cross-functional and international activities and given an opportunity to grow while working in an international well-funded company with a focused growth strategy.
A skilled coordinator with a personal drive for results
To succeed in this position, you have a superior overview with an analytical and data driven mindset. You handle issues pro-actively, and you are known for your ability to communicate with numerous and versatile stakeholders with a positive attitude.
Moreover, you have:
⦁ Bachelor's degree in engineering (chemical, industrial, pharmaceutical, mechanical), pharmaceutical sciences, chemistry or any related science degree required.
⦁ Master of Science degree preferred.
⦁ Comprehensive knowledge of API pharmaceutical unit operations and regulatory and GMP requirements in the industry
⦁ 5+ years of professional experience in the API pharmaceutical industry is preferred
⦁ Relevant experience with technical transfers
⦁ Strong analytical skills, with ability to process complex data sets into useful information
⦁ English at business level required, Danish preferred
Deadline and additional information
Please send your application and CV no later than 31 August 2022. For additional information about the position, please contact Senior Manager Global Manufacturing Science and Technology API, Rune Prior Rune Prior on +45 21916766.
Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
Connect with us on LinkedIn
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 4.4.2022, men kan have været deaktiveret og genaktiveret igen.
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