Technical Operations Manager
Kyowa Kirin
Marlow, England, United Kingdom
6h ago
source : Experteer

WE PUSH THE BOUNDARIES OF MEDICINE.LEAPING FORWARD TO MAKE PEOPLE SMILEEverything we do at KKI, is rooted in the idea of leaping forward to make people smile.

We are committed to innovation, for the benefit of the patients who count on us to support them. From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis our team is proud of all we deliver, but also humble in knowing how much more needs to be done.

By listening to patient stories, we gain a better understanding of the obstacles patients and their families face so we can work to better meet their unique needs.

The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their well-being through our work.

While the journey is not easy, it is one that is filled with purpose.Technical Operations ManagerKyowa Kirin Limited, Galashiels, MarlowScotland, England, UKRESPONSIBILITIES : Lead all Technical related functions for each project including pre-formulation, formulation, analytical & process development, clinical manufacturing & packaging, scale-up, technology transfer, validation, launch and post-market support.

Interact with third party manufacturers to provide technical support during process development, scale-up, technology transfer and commercializationProvide technical and strategic guidance to Project Management, Quality, Regulatory and Manufacturing, in supporting development and launch of projectsAuthor or assist in the production of regulatory Technical documentation required by global regulatory agencies for submissionsIndependently identify, prevent and solve technical problemsParticipate in budget planning and financial assessmentsQUALIFICATIONS : BSc / MSc in Chemical Engineering, Chemistry, Pharmacy or related scientific field with a minimum of 10 years or Ph.

D. with 5 years relevant experience in the pharmaceutical industry or related field4 / 5 Years hands-on experience within the pharmaceutical / biotech or allied industry in a Technical or manufacturing / QA / regulatory roleFamiliarity with cGMP (EU and USA), DEA, and FDA regulations and SUPAC and ICH guidelinesAn understanding of various dosage forms and experience with commercial pharmaceutical manufacturing processes and equipmentExperience working with CMOs, vendors and suppliers and maintaining successful partnershipsPhysical Requirements : Able to travel regularly ( 25%) within the EU and overseasGood PC Skills with experience in Word, Excel and PowerPointTypingUse of VDUKey Competencies specific to the roleExcellent inter-personal skills, ability to work within a team influencing others yet also able to act on own initiative and take decisionsThis role requires a natural and open style of management, flexible, decisive and able to plan and deliver promised outcomesAn out-going personality who has, and is able to establish, a good network of contacts in industry, regulatory affairs and academiaIn-depth understanding of regulatory requirements governing development, manufacturing and control of pharmaceutical productsPractical experience in the preparation and review of new applications, variations and responses to health authority questions including practical experience with EU Agency or FDA inspectionsKyowa Kirin Core Competencies : Results Oriented, Sense of Urgency and Flawless in ExecutionBENEFITS : In return for your talent, we will provide support through smart working, adopting best practice, deploying the latest technology and ongoing personal development.

Plus : Competitive salaryBonusPension schemePrivate medical insuranceTo meet the expectations of our patients and to truly deliver on our Commitment to Life, we are continually looking for people who embrace this spirit.

We are committed to providing a culture that offers both inspiration and reward in terms of compensation and in work satisfaction.

And in turn, we want people who’ll bring their unique ideas and diverse approaches, while also aligning to our ultimate goal of making people smile.

If this sounds like a company that aligns with your values, we’d love for you to join us in our / careersKyowa Kirin International is an equal opportunities employer.

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