LSC have a great contract opportunity for a Sr Specialist MS&T to join a leading biotech company based in Dublin.
If you have 5+ years of experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Serving as a biologics analytics and characterization subject matter expert, providing technical input to teams, and coaching to associate staff. Provide technical leadership for:
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- Experimental design, execution, data analysis and interpretation.
- Development,transfer and qualification of assays.
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- Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
- Technical point of contact for Process Analytical Technologies (PAT)
- Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), work instructions
- Technical lead for characterization testing, ensuring testing conducted either internally or externally
- Serving as a key member during internal audits and external inspections/audits
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- This role requires an experienced individual with a minimum of 6 years' (for MSc), 8 years' (for BSc) directly related experience in academia, pharmaceutical or biotechnology company - along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
- Experience with analytical testing in support of upstream cell culture and downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
- Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews.
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available currently.
Apply via this advert or contact Adam Murphy on 021 4777 329 if you have any more questions about this opportunity!
