TSMS Scientist required for Biotech client based in Kinsale, Co. Cork. Contract role.
The successful candidate will be required to provide technical expertise in the area of responsibility and demonstrate strong data-driven decision-making and problem-solving capabilities.
Responsibilities:
- 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
Requirements:
- 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.
- 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
- Some flexibility may be required to support 24/7 operations and issue resolution with external partners in different time zones.
Please call James Farrar today for further information on 087-2489961 or email: jfarrar@careerwise.ie
CareerWise Recruitment (In Search of Excellence) N.B. It is essential that you hold a valid working visa for Ireland Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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