LSC have a great contract opportunity for an Associate Scientist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
* Own and/or support analytical change controls for changes to global test methods or regulatory filings. Author, review, and manage change control process for (e.g., method changes, specification updates, equipment/instrument changes, site transfers) within the electronic Quality Management System (eQMS). Track change control timelines, ensure on-time closure, and escalate delays or roadblocks to management.
* Own and/or support analytical method transfers and validations in GMP Quality Control labs, both internally and externally - including generation of protocols, reports and acceptance criteria, co-ordination of execution, project management, and provision of program updates to leadership.
* Partner with Quality, Manufacturing, Supply Chain, Regulatory Affairs, Technical Services, and external stakeholders to ensure successful execution of analytical and process-related changes.
* Ensure all activities comply with cGMP, regulatory guidelines (FDA, EMA, ICH), and internal SOPs.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* Advanced degree (MS/PhD) in a science or pharmaceutical-related field - Chemistry, Pharmacy, Biology or Chemical Engineering.
* 1-4 years of experience in a pharmaceutical/biotech environment, with exposure to Change Control, Technology Transfer, Quality Systems, or Analytical Sciences.
* Experience with eQMS platforms (e.g., Veeva) is a plus.
* Familiarity with analytical techniques (HPLC, Empower, etc.) and method validation/transfer principles is desirable.
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 Amy Smyth on 021 4777329 if you have any more questions about this role!
