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Senior Specialist in Biotechnology

2 weeks ago

Dublin, Dublin City, Ireland Life Science Recruitment Full time
About Us

We are a leading recruitment agency specializing in life sciences recruitment. We have a strong reputation for delivering high-quality candidates to our clients across the industry.

The Opportunity

We are seeking a highly experienced individual to join our team as a Senior Specialist in Biotechnology. The successful candidate will have a strong background in analytical characterization and regulatory compliance.

Key Responsibilities
  • Serving as a biologics analytics and characterization subject matter expert, providing technical input to teams, and coaching to associate staff.
  • Providing technical leadership for experimental design, execution, data analysis and interpretation, as well as development, transfer and qualification of assays.
  • Leading and supporting various manufacturing science and technology organizational initiatives as needed.
  • 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.
Requirements
  • 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 assay development and qualification of biologics assays (HPLC-based, ELISA, etc). Familiarity with potency assays, including cell-based assays.