We are currently looking for an Associate Director to join a leading pharmaceutical company located in Co. Mayo, Ireland to support the Parenteral Product Development Science and Technology team.
The Poduct Development Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of parenteral products. The product portfolio includes a diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from clinical proof of concept through commercial product launch.
You will join a world-class team of engineers, scientists and leaders driving the advancement of industry leading process capabilities and the company's pipeline of innovative medicines. This role provides opportunities to work with global and cross-functional teams to develop innovative products and drive exceptional science. The Process Development group is responsible for programs that are transitioning from development through optimization and commercialization. They lead final process development, optimization, and validation, ensuring all processes are fit for commercial manufacturing.
Key deliverables include product control strategies; comprehensive data packages that drive product and process understanding that establish approvable marketing application submission content. We are looking for a highly motivated person, a discipline expert and, a manager of a technical group, who will drive New Product Tech-Transfer of Pipeline products into the lab. The successful candidate will be the principal technical/scientific interface between the sending site and the commercial receiving site.
Responsibilities will include:
- Provide leadership and talent development for a team of scientists responsible for a suite of late- stage biologics products will be responsible for ensuring new products and manufacturing processes are developed and ready for routine commercial manufacturing
- Ensures that a robust Design Space for the proposed manufacturing process is delivered as part of any transfer to commercial operations.
- Develops and maintains timelines for Tech-Transfer activities ensuring they meet functional and company goals.
- Collaborates with experts within Operations and R&D to integrate scientific and engineering objectives into activities associated with development of new/improved products or technology.
- Proactively advises and shares knowledge and expert opinions with subordinates, peers, and senior management.
- Mentors and trains functional colleagues and assesses current and emerging business challenges enabling functional goal achievement.
- Ensures delivery of major project plans within function through sound design, early risk assessments, and implementation of fallback strategies.
- Applies imagination and innovation by creating, inventing, and implementing new or better approaches, alternatives and breakthrough ideas that are valued by customers within the function.
- Presents scientific concepts and results for functional scientific and non-scientific leaders/stakeholders as well as potential and existing partners. Maximizes impact and value of expertise.
Qualifications
- PhD (8+ years), Master's Degree (14+ years), or Bachelor's Degree (16+ years) in scientific / Engineering discipline (e.g., Chemistry, Chemical/Process Engineering or related discipline) with previous manufacturing/laboratory experience.
- Previous supervisory experience managing teams required.
- Practical experience with process development working in a GMP environment is required including designing studies, authoring protocols and reports etc.
- Experience with investigations, validation events, out of specification, or out of trend evaluations preferred.
- Practical experience and strong knowledge of Sterile processing, Fill finish, Lyophilisation is preferred.
- Solid understanding of pharmaceutical process development in a cGMP environment. ·
- Ability to multitask and work within timelines.
- Demonstrated scientific writing skills and strong verbal communication skills.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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