Associate Principal Scientist, Analytical Program Lead - Hybrid
Job details
Job Description Analytical Research and Development is seeking an experienced analytical program management professional, to join our Large Molecule Analytical Validation team atour new State of the Art single use Multiproduct Biotech facility at Dunboyne Biologics . The primary responsibility is to lead and oversee the development and delivery of a programme -specific analytical strategy and management of analytical timelines and deliverables for commercial - facing in the areas of :
- monoclonal
- other complex therapeutic proteins
- vaccines in our large molecule portfolio
- Manage and serve as primary point of contact for analytical milestones to management and key stakeholders (program Development and Commercialization Teams, Global Quality, large molecule analytical development organizations and CMC Regulatory Affairs ) .
- Supports the development of an integrated control strategy through the utilization of Quality by Design tools
- Maintain and communicate timelines using project management tools.
- Identify and communicate risks, issues, and opportunities proactively and develop mitigation strategies to overcome challenges .
- Support analytical technical experts and regulatory colleagues in authoring of relevant regulatory submission analytical sections.
- Lead or assist in the development and refinement of above-program strategic plans and objectives , for example reference standard , specifications, critical reagents, etc.
- Represent the analytical organization on governance teams.
- BSc degree in Chemistry, Biochemistry, Engineering, Pharmaceuticals or related field with 12 years of relevant experience, or MSc with 7 years of relevant experience or PhD with 4 years of relevant experience.
- Validation and transfer oversight experience .
- Project management experience tracking, supporting and communicating timely delivery of milestones.
- Ability to work independently and within cross-functional teams, in-person and remotely.
- Effective communicator, influencer and partner both internally and externally .
- Strong knowledge and experience in application of current Good Manufacturing Practices (cGMP) to analytical activities within a quality management system and with health authority submissions and interactions.
- Willing to travel up to 25% domestically/internationally.
- M anaging therapeutic product analytical programs and experience in a quality control or an analytical development organization.
- F amiliarity with typical analytical techniques used for large molecule batch release , stability , and characterization testing .
- E xperience using project management, validation and Electronic Document Management Systems (e.g., scheduling tools, PowerBI , Trackwise )
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