Collins McNicholas

Job Purpose:
The purpose of this role is to provide chemistry expertise in delivering technical projects for the Technical Shared Service group.

Role Responsibilities:

  • Provides chemistry element of the prioritised process improvement projects
  • Provides chemistry element of the prioritised 2nd generation improvement projects
  • Provides technical support to product transfers into/out of non-NPI sites and 3rd party sites
  • Supports other groups in a matrix managed environment to support delivery of network priorities
  • Supports and helps define knowledge management standards for chemistry in the network

Quality Responsibilities:

  • Read and understand all relevant Quality Management System documents and Operating Procedures relevant to your job role.
  • Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements to ensure cGMP standards are maintained
  • Participate fully in our quality initiatives and attend training and complete assessments as required.

EHS Responsibilities:

  • Read and understand the EHS Systems documents and Operating Procedures relevant to your job role.
  • Ensure risk assessments, risk communication and action planning are completed in accordance with our Risk Management System (RMS)
  • Ensure that all incidents and accidents are reported to determine root cause and that any subsequent CAPA’s are closed out in a timely manner.
  • Lead by example to demonstrate the right EHS behaviours and encourage others to improve our safety culture

Role Requirements:

  • Proven experience in working within multidisciplinary teams in support of API manufacturing to achieve successful delivery of projects
  • Proven ability to engage, negotiate with and influence managers and stakeholders across discipline, functional and geographical boundaries
  • Self-starter with strong self-management skills
  • Excellent communication skills
  • Capability to assess and meet customer demands to create effective business solutions
  • Proven ability to drive for and deliver results – SLA focus
  • Demonstrated ability to think critically and innovatively combined with willingness to challenge
  • Proven resilience skills in a previous role
  • Demonstration of the use of OE and other investigative and business tools that supports embedding of an OE culture – at least OE Advocate trained
  • Strong technical skills. Must be a graduate in chemistry and/or a demonstrated track record in the Pharmaceutical Industry in a technical role. (PhD or masters in organic chemistry preferable)
  • Demonstrated excellent laboratory skills including working knowledge of EHS, GMP and Quality standards
  • Self-sufficient in key analytical methods ie. HPLC & NMR
  • Strong technical knowledge depth in all aspects of API support from laboratory through to plant application with considerable experience in process development, DoE & process scale up.
  • Proficient in organic synthesis and demonstrated ability in solving complex problems
  • Excellent presentation & report writing skills
  • Awareness of statistics and its application
  • Awareness of process engineering and its application eg. Unit operations, compatibility, control, commissioning
  • Understanding of key strategic technologies and their application to API manufacture and understanding of where their application can deliver business benefit
  • Developing knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9) for API
  • Knowledge of core secondary unit operations
  • Knowledge of consumer healthcare function

 

For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email rory.walsh@collinsmcnicholas.ie

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!

 

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)

Comment

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Biopharma Report

biopharma industry report biopharmaceuticals
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More