R&D Formulation Support Scientist

HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Aisling Kidney
email careers@hero.ie

R&D Formulation Support Scientist

Apply Now

Job ID: JOB-12136
R&D Formulation Support Scientist

Our client, a leading pharmaceutical company in Galway is looking for a R&D Formulation Support Scientist to join their team within in their R&D function. This is a permanent position where you will be reporting to the R&D Formulation Manager. We are looking for someone who will support and drive the vision to be the most valued global provider of high quality, competitively prices pharmaceutical products and to proved excellent services and support to their customers.

Responsibilities

  • Support Senior Formulators in preparing and executing Lab development trials to support the successful development of formulation.
  • Support R&D senior formulators and method development / validation analysts in planning and coordination of the formulation planning and testing.
  • Prepare orders to R&D production, bill of materials, batch manufacturing and packaging documents, validation protocols /reports stability protocols under the guidance of Senior R&D Formulators.
  • Provide support to Senior Formulators during development and scale-up and process designing of formulations for US/Europe/Canada/US/Australia and global markets.
  • Assist Senior Formulators in the Co-ordination with external sites such as API sites, packaging sites, excipient suppliers etc., to research and identify suitable options for new developments
  • Support internal teams such as procurement, planning, manufacturing, QC, QA in R&D formulation activities.
  • Perform site technical transfer activities from external sites
  • Support Senior formulation and R&D analytical teams in preparing technical responses to Customer and / or Authority deficiency questions on R&D developments.
  • Prepare R&D Techpacks for new developed products and submit to Regulatory Affairs team
  • Draft Development reports for R&D products under the guidance of Senior Formulators
  • Ensure the formulation log books/experiment registers are documented completed and in full at all times.
  • Co-ordinate with planning/production/validation/external and internal testing teams to ensure timely completion of process validation batches, Certificates of Analysis and associated reports.
  • Co-ordinate with procurement/Engineering to ensure availability of required documentation and suitability of packaging materials on the exiting lines.
  • Assist Senior Formulators in the execution of optimization and pilot batches.
  • Technical support to production for resolving any issues on the routine production batches
  • Support the R&D department in audits and inspections.
  • Comply with all the relevant regulatory guidelines for European and US FDA, ICH guidelines for development, process validation and stability studies.
  • Drive efficiency and effectiveness within the R&D team and the processes employed in R&D team.

Competencies

  • Knowledge of formulation development and tech transfer for the solid oral and liquid oral dosage forms in pharma companies in previous role/s.
  • Knowledge on the regulatory requirements for EU/Canada/US/Australia and ROW
  • Establishes strong working relationships with others, building team rapport and creating a cohesive team environment.
  • Displays a positive outlook with strong coaching skills, maintaining interest at all times.
  • Takes a methodical, systematic and structured approach to organizing work.
  • Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
  • Ability to build relationships and collaborate with others is vital.
  • Makes effective and consistent decisions in a timely manner.
  • Takes personal responsibility for making a decision and taking action within their own area.
  • Escalates issues appropriately.
  • Takes action to correct poor performance by being fair and consistent in approach.
  • Displays flexibility, willingness to succeed and goes the extra mile.

Key Requirements

  • 3rd level Science / Pharmacy qualification as a minimum.
  • Post- graduate qualifications in pharmaceutical sciences is preferable.
  • At least 3 years experience in the pharmaceutical industry.
  • Experience working within a pharmaceutical Environment; with knowledge of EU GMP and US FDA Guidelines
  • Excellent written and communication skills.
  • Strong verbal and written communication skills
  • Strong computer skills in MS Office

For further information on this role in Galway please contact Aisling Kidney on 0872197421 or careers@hero.ie

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.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Aisling Kidney

JOB-12136

Apply Now

R&D Formulation Support Scientist

Aisling Kidney

Role Type Permanent
Contact Aisling Kidney
email careers@hero.ie
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