Collins McNicholas

Responsibilites include:

  1.  To coordinate and lead all R&D and Operations related formulation development activities and to ensure strict adherence project plans.
  2.  To perform all activities required to ensure that all R&D project milestones are delivered according to agreed timelines.
  3.  To work closely with PMO to ensure all work stream leads are appointed to all ongoing projects and all planned tasks are being progressed.
  4.  Apply a thorough knowledge of pharmaceutics to the development of drug products and the interpretation of in-vitro data to predict in-vivo performance.
  5.  Interpret in-vivo data for the purposes of further formulation development.
  6.  Communication of project data through presentations at internal meetings and through formulation development reports.
  7.  Provide guidance and lead pivotal scale cGMP exhibit batch manufacture based upon a sound knowledge of site and departmental SOPs, and an understanding of ICH/FDA/EMEA requirements as they relate to formulation and process development activities.
  8.  Maintain a comprehensive knowledge of formulations and process development disciplines through research and scientific literature.

  1.  Project Planning:
  2.  Actively plan on-going formulation development requirements; ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
  3.  Determine tasks and resources required to deliver each project milestone by breaking them down into tasks; identify equipment, materials and people needed.
  4.  Proactively build effective working relationships with Core Team and Functional Members.

 

  1.  Compliance:
  2.  To ensure that work carried out follows required standards conforming to company, cGxP, SOPs, regulatory regulations & guidelines, safety and environmental guidelines.

 

  1.  Initiate action to correct quality/schedule problems or notify others of quality issues as appropriate. If a procedure does not exist, devise one; if a process needs amending, do so.

 

  1.  To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.

 

  1.  To support all on-going formulation and regulatory functions & requirements.

 

  1.  To complete all documentation correctly in order to achieve a high level of customer satisfaction and cGMP.

 

  1.  To prepare pharmaceutical development reports and submission documentation in support of licence applications to various regulatory authorities.

 

  1.  To perform additional team tasks as agreed to support effective running of the Business.

 

  1.  Health & Safety
  2.  Ensure requirements of Safety Statement are implemented
  3.  Continuously promote a positive safety culture by leading by example
  4.  Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
  5.  Report any defects
  6.  If unsure about safety requirements – ask

The ideal candidate will meet the following criteria:

  1.  Qualified to a minimum of honours degree level in Pharmaceutical science or related discipline. Master’s degree would be advantageous
  2.  At least five years’ experience working in a formulation development, or related technical environment
  3.  Experience in effectively operating both GMP and Non-GMP areas
  4.  Pre-formulation experience, including drug characterisation and ingredients selection
  5.  Formulation studies, considering such factors as particle size, polymorphisms, pH and solubility, as all can influence bioavailability and drug activity
  6.  Supervisory/ management experience essential
  7.  Analytical/ laboratory experience would be advantageous
  8.  Project management and team leadership skills are essential
  9.  Have demonstrated effective research skills, including the critical review of the scientific literature

For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email eloisa.ruiz@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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