Job Description
Our client enjoys a strong reputation as a company that is highly respected, a sought-after place to work where career development and advancement is enabled in a positive, patient focussed, collaborative environment. This highly ambitious, fast growing multinational biopharmaceutical company has an exciting pipeline of innovative drug compounds at an advanced stage in research.
Job Spec.
Reporting to the Exec Director Manufacturing Sciences function within the Process Development and Manufacturing Sciences (PDMS) group the role will provide scientific and technical leadership to Analytical Technologies and associated aspects of Analytical Characterization Technologies to support New Product Introduction and Commercial Products.Provision of technical subject matter expertise to the network Quality, Regulatory and Manufacturing
Operation groups during complex laboratory and manufacturing investigations, Tech Transfers/New process introductions, and/or other activities associated with Lifecycle Management as required.
Be an active and visible change agent, promoting a flexible and open mindset that embraces new opportunities, challenges the status-quo and drives for excellence.
The role will involve significant cross functional collaboration with other functions including Process Development, Quality, Manufacturing Operations and Regulatory, working towards existing and new product introduction to ensure smooth transition from Development to Manufacturing Operations and ensuring all analytical related aspects are understood, robust, efficient and in control.
Other responsibilities will include cross-functional team leadership and / or membership.
Essential Functions.
- Lead Analytical Strategy development and deployment to support ’s Product Portfolio.
- Identify and champion standards of practice, implementation and harmonization of technical programs/projects related to improve methods, laboratory operations, and new technologies applicable to in-process, characterisation and release testing, QbD, and/or PAT application.
- Identify and lead complex analytical methods robustness programs, optimisation and analytical characterization programs supportive of lifecycle management framework.
- Support method transfers and analytical technology transfers in partnership with ’s Quality Control organization.
- Develop strategic partnership with ’s Commercial Product Teams, CMC Teams and Manufacturing Sites Network (Internal and External).
- Work according to the guidelines established by relevant Governance bodies.
- Provide technical input and guidance to analytical groups across ’s network regarding the strategic and technical direction of training, experimental design activities, evaluation and qualification of new technologies.
- Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences.
- Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, influence and lead.
- PhD in Biochemistry, Biology, Chemistry or related field strongly preferred.
- 10+ years relevant experience in the Pharmaceutical Industry.
- Extensive knowledge of Analytical Technologies and Analytical Characterization Technologies.
- Strong track record developing, qualifying and validating analytical methods.
- Extensive experience working in cross functional teams in a pharmaceutical industry environment.
- Wide-ranging experience in pharmaceutical manufacturing with a strong background in Analytical Technologies.
- Demonstrated technical proficiency, scientific leadership, collaboration with others and effective decision maker.
- Excellent organizational, verbal, communication and presentation skills.
Ability to effectively lead and participate on multi-disciplinary teams. - Strong record of achievement in the pharmaceutical manufacturing environment
- Demonstrated expertise in New product introduction and Manufacturing Operations.
- Demonstrated track record of training and coaching colleagues.
- Responsibilities may require working outside of “normal” hours, in order to meet business demands.
Cv to gerry@rftgroup.ie