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Scientific Leader for Analytical Development

1 week ago

Cork, Cork, Ireland Scientific Update Ltd. Full time

Company Overview

At Thermo Fisher Scientific, we enable our customers to make the world healthier, cleaner and safer. Our team of 100,000+ colleagues shares a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

About Us

We value diverse experiences, backgrounds and perspectives. Our mission is to empower our customers to create a better future.

 

Job Description

The Analytical Development Manager will play a key role in the Process Development Services Team, collaborating with clients to introduce new products. This position will direct a team of analytical chemists to support analytical transfer, development, validation and troubleshooting activities to support our customers in developing medicines for patients.

Responsibilities:

  • Provide technical support to the analytical development team
  • Support troubleshooting and problem-solving activities and coach the team members to increase their capability
  • Provide mentorship to the project teams to ensure that they achieve their results
  • Lead analytical discussions with customers and communicate with SMEs in the Process Development, Project Management, QA, QC and IPC groups
  • Ensure that safety standards and housekeeping standards are met and encourage a safety mindset
  • Support compliance activities to ensure the team is 'inspection ready' at all times
  • Lead analytical technology transfer activities for the site and transfer analytical methods to the QC and IPC labs
  • Instill a continuous improvement mentality in the team and look to improve and simplify ways of working
  • Evaluate new analytical technologies
  • Work closely with the chemistry development team to provide support to projects as required
  • Support and guide the analytical chemists in their professional development ensuring that they have the required technical training and opportunities for personal growth
  • Author or contribute to regulatory submissions, patents and other internal documentation relevant to the role
  • Develop/Expand scientific, technical, and drug discovery knowledge by reading the peer reviewed scientific literature, attending scientific conferences and via relevant training
  • Work with due care and attention, perform all quality, regulatory and safety duties in a compliant manner whilst acting always in accordance with the Dignity at Work Policy and Code of Conduct

Minimum Requirements/Qualifications:

  • Degree, Masters or PhD in analytical chemistry
  • Extensive proven experience in an analytical chemistry environment. Experienced in analytical method development, troubleshooting, validation and transfer
  • Ideally some experience in a CDMO environment
  • Experience in managing a team
  • Proficient knowledge of analytical chemistry, particularly in method development, troubleshooting and analytical transfer
  • Experienced in HPLC, UPLC, GC, LC-MS, GC-MS, ICP
  • Experienced in analytical technology transfer and in change control
  • Proven ability to think critically and innovatively combined with willingness to challenge
  • Demonstrated ability in troubleshooting and solving complex issues
  • A strong understanding of the regulatory and compliance requirements for analytical methods and specifications. Knowledge of ICH, FDA/EMA guidelines and USP, PH. Eur
  • Excellent technical writing skills and verbal communication are required to interact with all levels of our organization and clients
  • Ability to work with cross functional teams and engage with employees and customers at all levels
  • Adept and participate in PPI (Practical Process Improvement) initiatives to identify improvements and cost saving to the business

What's in it for you?

  • Annual bonus
  • 25 days holiday + Good Friday + Christmas Eve
  • Contributory Pension
  • Private medical insurance
  • Free onsite parking