Team Horizon is seeking an Associate Director, Technical PDS&T for our client based in Mayo.
The Product Development Science & Technology (PDS&T) organization will lead the PDS&T Analytical organization at Mayo Ireland, and is responsible for providing technical leadership, direction and management of the Analytical PDS&T team and global initiatives and development programs.
The Analytical PDS&T team develops, validates, transfers and maintains analytical methods for New Biological Entities and marketed products and defines global analytical strategies.
The Associate Director leads these activities using state-of-the-art development approaches resulting in high-performing and robust analytical methods that ensure successful late-stage development for pipeline programs, submission of global regulatory filings and assurance of supply of on-market products.
The Associate Director recruits and manages department personnel, sets priorities, and manages employee development.
The Associate Director ensures that the function's deliverables are completed within established timelines, budgets, resource allocation and in accordance with regulatory, quality, and safety requirements.
Why you should apply: * This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people's lives.
* Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing: * The Associate Director provides technical leadership for multiple late-phase pipeline projects and commercial products that are marketed globally.
* Guiding cross-functional late-stage development and validation of analytical methods, global method transfers to troubleshooting and life-cycle management of test methods used for commercial products.
* The portfolio of analytical technologies includes physico-chemical methods but also complex cell-based potency assays.
* Leads and supports global and local project teams, liaises with early development functions in R&D, interacting with other functions in Operations, Regulatory as well as relevant technical plant functions.
* Leads activities executed at global external partners (CDMOs, Third-party laboratories) and method transfers to global regulatory agency laboratories.
* The Associate Director leads global initiatives, defines CMC/analytical strategies for global product development programs and can represent the company in discussions with various regulatory agencies.
* Due to nature of the projects and support of marketed products, the impacts of decisions are significant to pharmaceutical Operations to ensure successful regulatory filings and global market launches and to minimize regulatory risks and back orders.
* Managing a team of scientists ranging from scientist to principal level scientists which includes goal setting, performance management, people development, promotion recommendations and salary management.
* Responsibility/ownership for content of quality and global regulatory submission documents, responses to health agency requests and post approval filings.
* Perform financial planning and execute budget responsibility.
What you need to apply: * BSc degree in a scientific or technical field preferably in Life sciences, chemistry or pharmacy required.
Masters degree and/or PhD is preferred.
The following combinations of education and experience are required: BSc and 10+ years of experience; or MSc and 6+ years of experience; or PhD and 4+ years of experience.
Must have 4+ years of experience in pharmaceutical industry in the field of analytical chemistry preferably for CMC development of biological products.
* Must have a record of demonstrated successful development or commercialization of products.
Expertise with development of cell-based bioassays and modern analytical development approaches per ICH-Q14, and statistics skills are a plus.
* Sound knowledge of applicable global regulations and standards affecting Pharmaceutical Products (e.g.
CFR 210/211, cGMP).
* Must display managerial ability via leadership, supervisory experience and administration in a cross-functional and global setting.
* Previous experience in leading people is required.
Has strong management and long-term planning skills.
Must be goal oriented, able to work within a team environment, self-motivated and understand the business needs to meet timelines.
* Able to work in a fast-paced, multi-disciplinary and dynamic environment with potential for changing priorities, with flexibility to support multiple development programs simultaneously.
* Very good verbal and written communication skills and the ability to interface with multiple areas within a global organization are essential