TS/MS Scientist

(Technical Services / Manufacturing Science)

In partnership with its client, a Global Pharmaceutical Company, Kenny-Whelan & Associates are currently seeking a TS/MS Scientist for the Cork area.

Profile:

The TS/MS Scientist will be responsible for supporting ongoing manufacturing at the Company’s External Partners through tasks such as process monitoring, response to issues, and improvements where necessary as well as providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups.

This is a Large Molecule (mAb - monoclonal antibody) position.

Duties:

Provide technical oversight for monoclonal antibody manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes.
Participate in resolution of technical issues including those related to control strategy and manufacturing.
Possess excellent technical writing capabilities including authoring of deviations and change controls.
Employ excellent communication skills to manage internal and external relationships.
Build and maintain relationships with development and central technical organizations.
Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
Maintaining mAb processes in a state of compliance with US and global regulations.

Educational / IT Qualifications

Bachelors (minimum) in Scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Biotech/Biochemistry/Biotechnology) strongly preferred)
3+ years of demonstrated hands on working experience and proficiency with biopharmaceutical manufacturing and working knowledge of regulatory expectations.

Key Experience:

Strong understanding of regulatory requirements and their application in a manufacturing environment
Proficient in data management practices across manufacturing operations
Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change
Proven ability to effectively communicate and influence across diverse technical and business teams
Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects

Additional Information:

Some flexibility may be required to support 24/7 operations and issue resolution with external partners in different time zones.

Please note that as this is a Contract role you need to be eligible to work in Ireland, hold a Stamp 1G or Stamp 4 Visa

All applications will be treated with the strictest confidence

Kenny-Whelan Contact:

For further information please contact Carmel Synnott on 087 7422268 or send your updated CV to [email protected]