Senior R&D Formulator – Permanent Full Time

R&D

BASIC SUMMARY:

This is an opportunity to be part of a dynamic team within the R & D formulation function. We are looking for individuals who will support and drive Chanelle Pharma’s 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 Medical R&D Manager

 

KEY RESPONSIBILITIES:

  • Perform the Lab development trials for successful development of formulation.
  • Provide Technical support to formulation development and scale-up of solid dosage and liquid dosage formulations and process designing for US/Europe/Canada/US/Australia and global markets.
  • Provide Technical support to boost evaluation of the new molecules which involves checking the feasibility of development and manufacturing within the in-house infra structure. Co-ordinate with Business development, registration and sourcing team to evaluate overall feasibility of new development.
  • Comply with all the relevant regulatory guidelines for European and US FDA, ICH guidelines for development, process validation and stability studies.
  • To drive efficiency and effectiveness within the medical R&D team and the processes employed in medical R&D area.
  • Provide Technical support to Registration for responding to the queries from the regulatory agencies.
  • Prepare Techpacks required for registration of new developed products and submit them to Registration within the set timelines.
  • Reviewing the orders to production, batch manufacturing and packaging records, R&D process validation protocols and reports stability protocols and reports and familiarity with Bill of Material.
  • Assist in the transfer of R&D medical products into production for API/site variation and or Jordan Products.
  • Preparation/Review and approval of all Development reports for R&D medical products
  • Ensure the log books/experiment registers are completed regularly.
  • Co-ordinate with planning/production/validation/Jordan teams to ensure timely completion of process validation batches and the reports.
  • Co-ordinate with procurement/Engineering to ensure availability of required documentation and suitability of packaging materials on the exiting lines.
  • Execution of manufacturing of optimization and pilot batches.
  • Technical support to production for resolving any issues on the routine production batches
  • Represent the company at the time of audits
  • Ensure monthly four hours training is conducted per person per month for the formulators
  • Any other activity as per manager’s instructions.

COMPETENCIES:

  • 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
  • Hands on experience on handling the machines used for R & D activities.
  • 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.
  • Demonstrate and lead on the values, initiatives and culture of an organization. Professional expertise.
  • A strong working knowledge of best practice processes, change management implementation.
  • Demonstrated ability in prioritizing key initiatives,
  • 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:

  • 3rd level qualification as a minimum.
  • Post- graduate qualifications in pharmaceutical sciences is preferable.
  • 8 – 10 years formulation development experience in the pharmaceutical industry.
  • 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
  • Excellent written and communication skills.

 

Senior R&D Formulator – Permanent Full Time

R&D