Senior Pharmaceutical Technology Scientist
Job ID: JOB-11939
Senior Pharmaceutical Technology Scientist
We are now recruiting a Senior Pharmaceutical Technology Scientist to join our diverse Pharmaceutical Technology team in Dublin on a permanent basis. The Senior Pharmaceutical Technology Scientist is responsible for the successful development, planning, execution, and support of project plans related to technology transfer and marketed product enhancement activities, ensuring site readiness at each project milestone.
Primary duties and responsibilities of the position are as follows.
• Ensure process robustness by advocating for the inclusion into early stage product development of production concerns and recommendations so that the site is able to consistently supply the new product in the production environment in accordance with site strategic plan objectives.
• Establish the expectation and standards, and the supportive environment, to ensure that project teams and support personnel have the capability to meet performance expectations. This includes building capability by providing ongoing coaching and mentoring and providing timely recognition as well as performance feedback and counselling.
• Lead on-site new product development projects and ensure the successful execution of the Technical Services site project program.
• Lead the preparation and execution of feasibility, NDA, pre-validation and validation protocols and reports that enable first time right execution of manufacturing processes.
• Ensure the Technical Services team observes the Corporate Tech Transfer guideline and that the knowledge milestones are executed and documented thoroughly.
• Maintain accountability for project team’s performance metrics that support the annual operating plan and site strategic plan objectives.
• Manage the repository of Technical Services records and ensure they are in line with the registered critical process parameters detailed in the NDA for each product.
• Ensure that all production batch procedural documentation, such as project change controls, change notices, risk assessment reports, process validation protocols and reports, new batch manufacturing records, and SAP BOMs, recipes and PI sheets, are current, accurate, and clearly define process and role responsibilities and that they are in place prior to the technical transfer of the process to manufacturing. Ensure records are updated as necessary post-transfer.
• Ensure data reports on own team’s performance are current, accurate, and distributed according to defined procedures.
• Lead the development of new Standard Operating Procedures for new technology and the continual improvement of the GMP procedural documentation (BMR’s, SAP PI Sheet, SOP’s, Forms).
• Lead the on-going technical analysis and support of newly transferred and existing products, including process optimisation, lifecycle management, batch scaling and timely troubleshooting, performing root cause analyses and recommending preventative actions • Serve as subject matter expert (SME) on the site’s products, representing the site to internal and external (FDA) stakeholders.
• Serve as lead on the Technical Services team to provide technical support during the implementation of new process technologies, including Qualification, FAT, IQ, OQ, and that they coordinate PQ and process validation.
• Ensure site personnel are educated and trained on new technologies being introduced as part of the NPI program and on new and existing process technology or procedural changes.
• Support and adhere to established processes and productivity targets.
• Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfillment of production goals.
• Recognize and report to immediate supervisor any issues or deviations from accepted standards.
• Provide status updates on own activities and productivity challenges according to defined procedures.
• Seek process innovation and continuous process improvement.
• Complete and conform to all training requirements for job role, including company-required and job role-specific training.
• Carry out and assist in the on-going training of new and existing department personnel, as appropriate.
• Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
• Prepare and conduct performance appraisals in accordance with Company guidelines.
• May lead department initiatives and projects.
• A third level qualification in Chemistry or related Science, preferably a Bachelor’s Degree
Technical Skills and Experience:
Proficiency of computer skills with Microsoft Word, Excel, Outlook. Technical expertise in the pharmaceutical technology and automated control systems
• 5 years related experience and/or training; or equivalent combination of education and experience.
• Experience in pharmaceutical manufacturing facility.
• Experience working with pharmaceutical processing technologies and good understanding of 21CFR / cGMP documentation and electronic systems requirements.
• Demonstrated experience applying sound and critical reasoning to troubleshoot complex process challenges.
• Demonstrated success in making effective and persuasive presentations on complex topics to upper management.
• Experienced in aligning individuals and teams to business objectives • Exposure to Lean manufacturing concepts a plus
• Experience in managing by metrics
• Exhibits a high personal drive for excellence and holds self and project team accountable for consistently high quality performance results.
• Demonstrates ability to lead a project team by personal example and inspire, motivate, and guide team toward attainment of team goals.
• Understands the vision, strategy, and goals of one’s own function and of the site, and adeptly defines, clarifies, and assigns tasks to project team members in a manner that ensures people and resources are deployed efficiently and effectively to successfully execute goals.
• Demonstrates ability to manage project team performance by setting clear goals, giving team members honest, clear, balanced, and timely feedback regarding strengths and areas for improvement, and providing regular coaching and guidance for team members to grow skills and improve performance. Provides timely recognition for positive contributions and achievements. Addresses performance issues promptly and fairly.
• Demonstrates ability to create a climate of trust, cooperation and shared responsibility among project team members by practicing participatory leadership and by effectively managing team dynamics and conflict, encouraging debate and skillfully settling differences to gain consensus. • Demonstrates ability to lead project team effectively under pressure and challenging conditions, maintaining focus and intensity and remaining optimistic and persistent while guiding team to achieve expected results.
• Models open communication and information-sharing, consistently keeping all stakeholders informed of own and team deliverables. Demonstrates ability to collaborate with colleagues across other functions and sites and use influence positively and skillfully to find common ground in order to achieve organizational goals.
• Uses experience, technical expertise, and established standards and methods to analyze and solve problems and exercises sound judgment about when to take action and when to escalate issues to the next level of expertise.
• Adept at evaluating, planning, and prioritizing own work, creating efficient workflows to manage multiple activities and using time and resources effectively to deliver results on or before deadline.
• Understands and supports the need for change and involves team in change initiatives and continuous process improvements.
• Demonstrates the desire and ability to grow own capabilities by seeking out and engaging in challenging learning opportunities that enhance contribution to site and advance professional and career development.
• Demonstrates a personal commitment to site safety by actively fostering a safety culture and upholding all safety standards in the performance of job duties.
For further information on this role in Dublin please contact Emma Griffin on email@example.com/0860334325 Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval
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