3 Drug Development jobs in Ireland
Sr. Engineer Drug Process Development Inspection
Posted 19 days ago
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The Sr Engineer will drive excellence and innovation in both large and small molecule drug product manufacturing at Amgen Dun Laoghaire. As a key player in our global Process Development organization they will be instrumental in ensuring the highest standards of process performance, while also leading the charge in innovative process improvement strategies.
+ Acts as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in inspection.
+ Drives the establishment of visual inspection objectives, focusing on regulatory expectations and network alignment.
+ Supports make-a-batch exercises to determine facility fit and identify gaps in the Visual Inspection process.
+ Supports New Product Introduction with visual inspection method development and AVI characterization.
+ Supports calculation of defect limit updates for new products and re-evaluation of current products.
+ Provides expertise on defects identified during batch inspection and supports defect library updates.
+ Supports in the development of visual inspection team members.
+ Support in the development of new inspection lines - URS / Vendor Selection
+ Provides support for manufacturing and commercial activities.
+ Assists in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply.
+ Assists in troubleshooting issues with drug product processing technologies and equipment.
+ Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities and lessons learnt to deliver high-quality manufacturing processes.
**Basic Qualifications**
+ Bachelors degree & 8 years of directly related experience OR
+ Masters degree & 6 years of directly related experience
+ Experience in a regulated and or vision related work environment Preferred
**Preferred Qualifications**
+ 10+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
+ Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.
+ Experience in working with vision related systems and validation of inspection equipment.
+ Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
+ Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
+ Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.
Assoc. Director, Business Analyst, Technical Research & Development (TRD)
Posted 8 days ago
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Job ID REQ-
Irlanda
SummaryLocation: Barcelona or Dublin
In this role you will effectively transform the business requirements into an IT solution design specification, ultimately leading to meeting the customer expectations while assuring solutions are safe, reliable, scalable and flexible.
You will act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis. You will also engage with global business leaders and leverage the appropriate Data Digital and IT (DDIT) teams and Functions to determine requirements and deliver data-driven recommendations to improve efficiency and add value
Role Responsibilities:
- Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable), DDIT Service Portfolio and with industry best practices in leveraging technologies for the business and taking advantage of reusable products, solutions, and services wherever applicable. Additional specification required for testing.
- Develop project rationale and perform scoping assessments to determine feasibility of projects. Highlight/identify gaps in existing functionality and review requirements with stakeholders.
- Develop a comprehensive requirement specification that will determine the estimate of cost, time and resources to deploy solutions. Develop project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.). Liaise with the service development team to suggest a high level functional solution.
- Ensure that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services.
- Ensure the overall user experience is taken into account when designing and deploying new solutions and services.
- Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT )
- Ensure implemented solutions are according to specifications and fit for purpose.
Support super user training.
Role Requirements:
- University degree in Informatics, Computer Sciences, Life Sciences or similar
- A minimum of 10+ years of experience in working in the Pharma or IT Industry with 8+ years of experience in the Lab IT domain
- A minimum of 6+ years of experience as a business analyst/process expert/ business IT lead superuser/Lab data or Digital position
- Expert understanding of business process analysis & design and system architecture concepts.
- Expert understanding of the Lab business processes, drug development experience an advantage
- Expert knowledge of GXP, 21CFR Part 11 and the CSV lifecycle
- Expert knowledge of Lab systems including LIMS systems, and Chromatography systems.
- Ability to solve complex business process / information challenges.
- Proficient skills in global teams, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution.
- Working knowledge of Project Management, agile an advantage
- Prior working experience in TRD and knowledge on TRD business processes is preferred.
- Innovation experiences an advantage, including digital innovation projects
- Data Strategy, Data science or data standardization experience an advantage.
Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours
Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
This role is based in Barcelona, Spain OR Dublin, Ireland. Novartis is unable to offer relocation support for this role:please only apply if this location is accessible for you
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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Assoc. Director, Business Analyst, Technical Research & Development (TRD)AI Research and Development Engineer
Posted 4 days ago
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