Job Description

　　Job Summary

　　The Process Development Services (PDS) Director is responsible for owning the process and analytical development activities within the Active Pharmaceutical Ingredients (API) business, ensuring that the process is appropriate for manufacture for the phase of development or product lifecycle.

　　The role combines knowledge of scientific and business issues to enable products that are developed, manufactured or distributed to meet all required legislation.

　　As a key member of the Site Leadership Team (SLT) for the Thermo Fisher Scientific Cork Site, they support the General Manager and the SLT in all aspects of the operation and in strategic planning. The leader will develop, mentor, and supervise professionals within this business area.

　　What Will You Do?

　　The PDS team will be key in interfacing with the customer during the development and technology transfer phase of a project. This includes the technology and analytical transfers of the products to the site. Process development of the products to ensure that the process is appropriate for manufacture for the phase of development or product lifecycle.Analytical development of the methods for testing of raw materials, intermediates and APIs as appropriate for the phase of development or product lifecycle.Process validation of new products and lifecycle changes. Responsible for the generation of the control strategy and validation and the supporting analytical methods.Transfer of products to Operations post commercial validation. PDS is responsible for ensuring that the process is fit for commercial manufacture. Transfer of methods to QC for testing of raw materials, intermediates and API at all phases of the product lifecycle. PDS is responsible for ensuring that the methods are appropriate for the phase of development or product lifecycle.Transfer of methods to IPC for in-process control testing of processes at all phases of manufacture and lifecycle. PDS is responsible for ensuring that the methods are appropriate for the phase of development or product lifecycle.Ensure that the basis of safety is in place for all products and that the appropriate safety testing has been completed for all.Material science characterization support and crystallization supportTechnical and analytical troubleshooting and improvements, as requiredKeep the team stays up to date with current technologies and manufacturing trends.Confirm a robust succession plan in the team for key roles.Make sure that there is a strong quality, EHS, PPI and compliance culture across the team.Managing the team Opex budget and supporting the planning of the capital requirements for the future.Models behaviours in line with the company values.

　　Keys to Success:

　　Educational

　　Minimum requirement of B.Sc Chemistry or B.Eng Chemical Engineering. It is preferred candidates would hold a M.Sc/M. Eng or Ph.D

　　Experience

　　Extensive experience in Pharmaceuticals, API manufacturing, BioPharma or similar Working knowledge of CDMO would be an advantage Experience in technology transferExperience in process developmentPractical knowledge leading multi-disciplinary teams at a Senior levelBudget managementDemonstrated leader with a solid foundation in Integrity, Involvement, Intensity and Innovation

　　Knowledge, Skills, Abilities

　　A decisive leader who's able to encourage and empower teams and can clearly communicate goals and objectives.Positive demeanour and service-minded approachExcellent written and verbal communication skills, including presentation skills.Demonstrated ability to communicate clearly, succinctly, and effectively in person, over the phone, and in writingComfortable presenting with executive management and clientsStrong interpersonal skills including the ability to remain calm, professional, diplomatic, and positiveAbility to work as a member of a team in a demanding environmentMust possess strong organizational skills, yet able to balance multiple projects concurrently

　　Benefits

　　In this senior leadership role you with receive a competitive base salary depending on experience, attractive annual bonus, car allowance, contributory pension, private healthcare, life assurance, 25 days holiday as well as other optional benefits that can be tailored to suit you!

　　About our Cork site

　　Operating for over 40 years, the Cork site is proud to manufacture and supply Active Pharmaceutical Ingredients (API) to our customers for use in clinical trials and approved medicines for commercial supply - medicines to treat Cancer, Parkinson's Disease, Depression, HIV, Congestive Heart Failure, Diabetes and Respiratory diseases, along with raw material for consumer healthcare products!

　　About us

　　When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 120,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.