Key Responsibilities

• The candidate will contribute to and/or lead cross-functional project teams associated with manufacturing process development, process characterization/justification, transfer of technology to manufacturing sites, and support manufacturing activities for peptides and potentially other modalities:
  • Provide leadership in a matrixed team setting, while acting as an SME for peptide processes, interacting with various cross-functional groups and stakeholders and contributing to AbbVie’s peptide manufacturing strategies.
  • Set project strategies, define project responsibilities and timelines
  • Author and review key regulatory documents, laboratory data, technical memos and reports.
• The position involves multi-disciplinary interactions with organic chemists, analytical chemists, engineers, and solid-state scientists.
• The position also entails interfacing with many groups external to PDS&T, for example: Manufacturing Operations, Regulatory Affairs, Quality Assurance, etc.
   

Responsibilities

• Effectively functions as a principal investigator, generating original technical ideas and demonstrating creative 'out of the box' thinking to solve difficult problems and champion new technologies to achieve project goals. Make significant contributions to project team through lab-based activities. Independently responsible for project science within his/her area of expertise on one or more project teams.
• Authors and/or reviews technical reports, manufacturing batch records and regulatory documents concerning Chemistry, Manufacturing and Control (CMC) subjects. Primary author of publications, presentations, and/or primary inventor of patents.
• Potential to mentor/supervise a team of one or more individuals, evaluate the performance of those individuals and be accountable for the effective performance of those individuals.
• Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.