LSC has an exciting opportunity for a TS/MS Scientist to join a pharmaceutical company in Cork. This will be a dynamic environment that is constantly innovating, relies on cutting-edge technology to deliver life-saving medicines. You will be working in a site that supplies active ingredients through complex chemical synthesis and biotechnology manufacturing processes for a range of therapeutics. This is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture.
If you have 3 + years of experience in the Technical Services in pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
The TS/MS (Technical Services / Manufacturing Science) Scientist will provide technical and scientific expertise within a dynamic external manufacturing environment. The Scientist is responsible for providing technical support to achieve the reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards.
ABOUT THE ROLE:
- Provide technical support and guidance for peptide 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, change controls and data integrity reviews (DIR)
- 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 Peptide processes in a state of compliance with US and global regulations
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 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.
Additional Preferences:
- Strong preference for demonstrated project management expertise with a track record of coordinating and executing multifaceted projects.
- Strong understanding of regulatory requirements and their application in a manufacturing environment.
- Proficient in data management practices and competent in executing thorough data integrity reviews 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Kathy Gillen at LSC on 021 4718212 if you have any more questions about this role!
