Technical Operations, Associate Director

Technical Operations, Associate Director
Technical Operations, Associate Director
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from The RFT Group
unique authority in executive search for global based innovation driven drug development companies
Technical Operations, Associate Director
Our client is a highly successful, and ambitious global biopharmaceutical company with a strong commercial portfolio and drug pipeline.
With a passion for best practice in every aspect of its business, this well-managed, high performing company has a motivated workforce who are passionate about operational excellence.
Job Spec
Our client operates a model of excellence through partnership via the virtual plant operating in a dynamic and flexible environment where our collective role is to ensure the end-to-end integrity of the commercial supply network to deliver quality medicines to our patients in a safe, efficient and value driven manner where diversity, inclusion and belonging are core values to our organisation.
This role requires a technical process expert to support new product introductions, technology transfers, continually monitor, troubleshoot and improve drug product and packaging operations conducted across the network.
This role ensures robust, compliant, and efficient processes for drug product formulation (solid oral, vial and syringe filling etc), technology transfer, and packaging operations.
The position requires cross-functional collaboration with functions such as Quality, Regulatory, Supply Chain, R&D and external partners (CMOs).
Responsibilities
Build and maintain influential relationships with appropriate stakeholders both internally and externally while providing technical leadership and packaging engineering expertise to external supply teams to support the management of CMO's in the supply network.
Provide technical input and guidance on drug product and packaging CMO vendor selections activities and drug product/packaging technical transfers in collaboration with Pharmaceutical Development and provide input to ensure network capabilities and competencies are available to tech transfer to CMO's should the network require alternative supply sources.
Lead implementation of new technology or upgrade projects at external CMO packaging sites in conjunction with internal stakeholders and external CMO's.
Provide technical input and operational support during the design and execution of packaging IQ/OQ/ PQ and PPQ qualification studies led by the CMO Validation / Validation (Dev & External Quality).
Contribute to technical input for primary and secondary packaging development where activity shall be performed by CMO and shipping development studies as required to support new product introduction.
Provide technical oversight at CMO's for Packaging Engineering trials, whether these are driven by new product introduction, change of secondary packaging components/ process, or internal change (change to primary containers or process) ensuring that appropriate controls are in place and detailed in Standard Operating procedures or Batch records, ensuring that these are continually updated to streamline and optimize the process.
Ensure Design Control is maintained for secondary packaging of commercial combination device products via initiation of design control document maintenance, design related change controls and execution of verification activities that are associated with CMO's.
Ensure that critical and key parameters are appropriately identified for all Packaging processes and that the Packaging Control Strategy is maintained as a lifecycle document.
Provide technical input and leadership support to drug product processes (solid oral, vial and syringe filling etc), exhibiting an ability to quickly comprehend technical processes, troubleshoot and continually improve processes with key stakeholders.
Contribute to regulatory filings and CMC as required.
Provide technical leadership into drug product and packaging investigations in conjunction with CMO and cross functional support teams to ensure root cause is identified and sustainable CAPAs are in place.
Responsible for the day-to-day process operations conducted by CMO's.
Process owner for the manufacturing processes and ensure the manufacturing process operates effectively and efficiently, to ensure excellence in the supply of products to our patients.
Work with network suppliers (internal and external) to maintain and publish KPIs that are focused on delivering the most efficient processes.
Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs, work in conjunction with other departments to ensure production, quality and safety targets are met and drive systems and processes to eliminate customer complaints.
Identify and mitigate risk through active participation in our risk management process.
Maintain and develop packaging competency library to be used as a reference point for existing and future product strategies.
Collaborate with PharmDev to develop new drug products and packaging designs that are suitable for commercial operations across the network.
Provide technical expertise and guidance in drug product manufacturing operations in areas such as process development, troubleshooting to determine root cause and input to potential future site and process selection for new products.
Person Spec
Engineering or Science Qualification (Bachelors/ Master's Degree preferred) with significant drug product and packaging engineering experience in high volume pharmaceutical and/or healthcare packaging, providing engineering support for new product/process introductions in accordance with EHS and cGMP standards in pharmaceutical or healthcare packaging industry.
Experience working in a cGMP environment with strong discipline with regard to change control and risk assessment to evaluate existing manufacturing processes and workflows to identify areas that could benefit from changes and improvements.
Proven problem-solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action and timely close out of investigations and associated CAPA's.
In-depth knowledge of primary and secondary packaging of pharmaceutical drug products (Tablets/Capsules/Vials/Syringe) with knowledge of global regulatory requirements related to design and control of these processes.
Drug product operations experience in areas such as oral solid dosage, vial and syringe filling.
Strong mechanical capability with hands on experience with equipment, preferably experience in a technical role within a high-volume manufacturing environment.
Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerances and associated relationship with materials, product and process design deployed within the packaging design.
An ability to quickly understand new technologies, comprehend operating principles and work with technical teams to troubleshoot processes.
Excellent verbal, written communications including technical report and investigation writing aligned with excellent presentations skills and influencing skills.
There is ~20% of domestic / international travel associated with this role.
Cv to 087 2834400
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Manufacturing
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at The RFT Group by 2x
Get notified about new Director of Operations jobs in
Dublin, County Dublin, Ireland
.
Dublin, County Dublin, Ireland 14 hours ago
Operations Associate (Part-Time) - Grafton Street
Dublin, County Dublin, Ireland 6 days ago
Dublin 12, County Dublin, Ireland €32,000.00-€35,000.00 3 weeks ago
Dublin, County Dublin, Ireland 15 hours ago
Dublin, County Dublin, Ireland 2 weeks ago
Operations Associate (Customer Support & Finance)
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 1 month ago
Dublin, County Dublin, Ireland 4 days ago
Dublin, County Dublin, Ireland 2 weeks ago
Ashbourne, County Meath, Ireland 1 week ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 2 weeks ago
Dispatch Agent (Operations) - FULL TIME - IRE
Dublin, County Dublin, Ireland 1 month ago
Operations Analyst, Slack Policy Operations
Dublin, County Dublin, Ireland 6 days ago
Dublin, County Dublin, Ireland €30,000.00-€34,000.00 2 weeks ago
Dublin, County Dublin, Ireland 1 month ago
Dublin, County Dublin, Ireland €60,000.00-€60,000.00 15 hours ago
Transport Operations & Commercial Driving Apprenticeship
Safety Model Operations Quality Assurance - Arabic
Dublin, County Dublin, Ireland 6 days ago
Multiple opportunities in Operations function
Dublin, County Dublin, Ireland 5 months ago
Dublin, County Dublin, Ireland 3 weeks ago
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 3 weeks ago
Dublin, County Dublin, Ireland 5 days ago
Search Trending Product Operations - Trust & Safety
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland €27,000.00-€27,000.00 2 weeks ago
Dublin, County Dublin, Ireland 5 days ago
Dublin, County Dublin, Ireland 6 days ago
Dublin, County Dublin, Ireland €30,000.00-€32,000.00 19 hours ago
General Manager's Assistant, SNN4 Operations
Dublin, County Dublin, Ireland 2 weeks ago
We're unlocking community knowledge in a new way.
Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr