HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Caroline Kingston
email Caroline@hero.ie

R&D Manager (Medical)

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Job ID: JOB-11885
R&D Manager- Medical My client a leading pharmaceutical manufacturer of both medical and veterinary products and is looking for an R&D Manager to join the Medical R&D formulation function. I am looking for individuals who will support and drive their vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.

The Opportunity: This is an opportunity to be part of a dynamic team within the QA function. We are looking for an individual who will support and drive the vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers. In this role you will report into the QA Manager Key Responsibilities

  • Responsible for the formulation of Chanelle medical pipeline products and the running of the R&D pilot scale manufacturing area within a GMP manufacturing facility.
  • The development and scale-up of solid dosage and liquid dosage formulations for the European and global markets.
  • Assist in the transfer of R&D medical products into production
  • Responsible for the placing of R&D orders to production, preparation of batch manufacturing and packaging records, R&D process validation protocols and reports stability protocols and reports and familiarity with Bill of Material.
  • Interpretation of analytical results i.e. formulations is required.
  • Preparation and approval of all Development and analytical reports for R&D medical products
  • Comply with all the relevant regulatory guidelines for European and US FDA, ICH guidelines for development, analytical, process validation and stability studies.
  • Overseeing process optimisation and process validation of medical R&D products.
  • Familiarity with operation principles of standard manufacturing equipment used in solid oral dosage forms and liquid dosage forms and GMP principals required for scale up batches (including biostudy batches)
  • Coordination with external formulation sites.
  • People management: Managing and developing direct reports to include coaching, motivating and ensuring adequate training in order to meet and exceed individual and team goals.
  • To drive efficiency and effectiveness within the medical R&D team and the processes employed in medical R&D area.
  • Work with the medical regulatory team to respond to all Authority R&D questions as required

Competencies

  • Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
  • The ability to plan and execute multiple development projects and to work in a busy development environment
  • Sound knowledge of formulation development and tech transfer for the solid oral and liquid oral dosage forms in pharma companies in previous role/s.
  • Sound knowledge on the regulatory requirements for EU/Canada/US/Australia and ROW
  • Project management experience is essential
  • Excellent written and communication skills.
  • Experience in the formulation of medical oral solid dosage forms, liquids and modified released products etc. Post graduate qualifications in Pharmaceutical technology an advantage
  • Demonstrate initiative in idea generation, experimental design and write reports with minimal consultation.
  • A strong working knowledge of best practice processes, change management implementation.
  • Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
  • Ability to build relationships and collaborate with others is vital.
  • Demonstrate and lead on the values, initiatives and culture of an organization. Professional expertise.
  • Positive and proactive person who is energized by having great responsibility
  • Practical, action-orientated approach to managing priorities and teams.
  • Strong computer skills in MS Office Qualifications
  • Masters in Pharmacy/PhD in pharmacy desirable
  • Have 15+ years formulation development experience in the pharmaceutical industry with at least 3+ years in EU formulation developments
  • Experience in the formulation of medical oral solid & liquid dosage forms.
  • Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines
  • Demonstrate initiative in idea generation, experimental design and write reports with minimal consultation.
  • Excellent written and communication skills.
  • Strong computer skills in MS office For further information on this R&D Manager role in Galway please contact Caroline Kingston on 086 8395531 caroline@hero.ie

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Caroline Kingston

JOB-11885

Apply Now

R&D Manager (Medical)

Caroline Kingston

Role Type Permanent
Contact Caroline Kingston
email Caroline@hero.ie
mobile +353 86 839 55 31
linkedIn profile click here

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