Analytical Chemist - Analytical Laboratory

Recruitment by Aphex

Dunboyne

On-site

EUR 55,000 - 75,000

Full time

31 hours ago
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Job summary

Recruitment by Aphex is seeking a QC Analytical Chemist for our state-of-the-art single-use multi-product biotech facility in Ireland. You will support the Quality Control testing function, conduct biological, chemical, and physical analyses using modern laboratory instrumentation, and help establish the lab as a hub for specialized analytical testing.

The role requires strong collaboration with self-directed work teams, adherence to cGMP, and a focus on continuous improvement and patient value.

Qualifications

  • Degree in Science, Technical, or Quality field.
  • 4 years' experience in biotechnology/pharmaceutical industry.
  • Excellent written and oral communication.
  • Knowledge of cGMP for Laboratory Operations.
  • Self-starter who works in a team.
  • Understanding of analytical methods (HPLC, GC, UPLC, Capillary Electrophoresis and wet chemistry).
  • Familiarity with GMP, ICH, USP and global regulations.
  • Experience with cross-functional collaboration and meeting schedules.
  • Experience with Cell Based Assays, ELISA and qPCR.
  • Organisational skills for multiple priorities.

Responsibilities

  • Strong project management to support delivery and readiness.
  • Strong stakeholder management with internal and external partners.
  • Proven ability to meet tight timelines.
  • Excellent influencing and collaboration within teams.
  • Troubleshooting and problem solving; coach self-directed teams.
  • Promote continuous improvement and challenge the status quo.
  • Think proactively under pressure and drive change.
  • Use lean tools to build team capability and efficiency.
  • Coordinate risk management within Quality Control.
  • Collaborate across the Network and with PDTS and Manufacturing.
  • Support QMR decisions with cross-functional data.

Skills

Project management
Stakeholder management
Timelines delivery
Collaboration
Troubleshooting
Lean / continuous improvement
Change management
Agile teamwork

Education

BSc/MSc in Science/Technical/Quality

Tools

HPLC
GC
UPLC
Capillary Electrophoresis
Wet chemistry

Job description

  • Primary Duties of this role will be part of Quality Control Testing Hub in the state-of-the-art single use multi-product biologics facility.

The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.

The Analytical Chemst in the Analytical laboratory will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement.

The QC Analytical Chemst in the Analytical Laboratory will support key laboratory start-up activities, conduct biological, chemical, and physical analyses by using state of the art laboratory instrumentation and computer systems at the new single use multi-product biotech facility.

The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations.

This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for patients.

Responsibilities
  • Strong project management skills to support project delivery and operational readiness.
  • Strong stakeholder management skills to manage both internal and external stakeholders that support the site.
  • A proven ability to deliver on tight timelines.
  • Excellent influencing/collaboration skills and teamwork mindset.
  • Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problems solving.
  • Ability to challenge the status quo with a continuous improvement mindset.
  • Ability to think logically and be proactive under pressure.
  • Proven ability in using a wide variety of lean tools and building capability within teams.
  • Change agent who will support the organisation with good change management tools and techniques.
  • Proven ability through working across teams focusing on meeting and tracking to schedules and embracing and interdependent work culture as an agile team member.
  • Support creation of a focus on creating a continuous mindset organisation through active coaching.
  • Effective communicator with a proven ability to develop capabilities of others in a team.
  • Demonstrated ability to give and receive feedback.
  • Excellent trouble shooting and problem-solving skills.
  • Ability to work as part of a team and on own initiative in a constructive manner.
  • Flexible and self-motivated.
  • Promoting a culture where diversity and inclusion is part of the DNA.
  • Establishes stretch goals for self to allow the SDWT or Hub Team deliver on their priorities.
  • Identifying and communicating risks in area of responsibility and across the site.
  • Creating strategies and plans to manage risk within the Quality Control operation.
  • Collaborates across the Network and continuous improvement teams across the Organisation.
  • Collaborates with cross-functional teams to deliver the site objectives.
  • For product quality, collaborates with Process Development Technical Services (PDTS) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
  • For safety, the individual is accountable to drive a culture of 'everyone owns safety'
Requirements
  • Degree Qualification (Science/Technical/Quality or related)
  • 4 years' experience in the biotechnology and/or pharmaceutical industry,
  • Excellent written and oral communication skills.
  • An understanding of cGMP requirements for Laboratory Operations and/or systems and compliance.
  • Required to work on their own initiative in addition to working as part of a team.
  • An understanding of analytical methodology (HPLC, GC, UPLC, Capillary Electrophoresis and wet chemistry methods).
  • An understanding of GMP, ICH, USP and global compendia regulations and guidance's,
  • Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g., DMIAC, Lean QA, 5S etc).
  • Proven ability around working cross functionally, focusing on meeting, and tracking to schedules and embracing an interdependent work culture.
  • Experience with Cell Based Assays, ELISA and qPCR
  • Organisation Skills - Ability to manage multiple priorities and know when to elevate issues for resolution.
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