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Senior Biopharmaceutical Specialist
1 week ago
Life Science Recruitment is currently seeking a skilled Senior Biopharmaceutical Specialist to join our team in an exciting opportunity with a leading multinational based in Swords.
This role is ideal for individuals looking to take on a challenging position in a dynamic industry, where they can utilize their technical expertise and leadership skills to drive success.
The successful candidate will serve as a subject matter expert in biologics analytics and characterization, providing technical input to teams and coaching associate staff.
Key responsibilities include:
- Providing technical leadership for experimental design, execution, data analysis, and interpretation.
- Developing, transferring, and qualifying assays.
- Leading and supporting various manufacturing science and technology initiatives as needed.
In addition, the candidate will be responsible for:
- Serving as a technical point of contact for Process Analytical Technologies (PAT).
- Authoring and reviewing documents, including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), and work instructions.
- Ensuring the quality and integrity of characterization testing conducted either internally or externally.
The ideal candidate will possess a minimum of 6 years' experience in academia, pharmaceutical, or biotechnology companies, along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
Familiarity with assay development and qualification of biologics assays (HPLC-based, ELISA, etc.), as well as potency assays, including cell-based assays, is essential.
