The Drug Product Development (DPD) group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), and novel biologic formats) from preclinical development through clinical proof of concept.
We have an exciting opportunity for a Principle Scientist I to join our team at our AbbVie Bay Area (ABA) site in South San Francisco, CA. This is an on-site role and will serve as our outsourcing lead for formulation and process development. This individual will be the primary technical interface between AbbVie and external Contract Development and Manufacturing Organizations (CDMOs), ensuring successful execution of outsourced drug product development. The role is responsible for driving external execution while partnering closely with drug product leads, operations specialists, and functional management to ensure alignment of strategy, timelines, risks, and deliverables and will be expected to take a first look at work packages, data and conclusions from CDMOs. The individual will serve as a technical representative of ABA DPD, providing leadership across internal and external teams to advance programs efficiently and compliantly.
Responsibilities
- Serve as the primary technical liaison between ABA DPD and CDMOs and ensure functional alignment with management and relevant stakeholders for all external drug product development activities.
- Lead external drug product development activities, including formulation development, process development, technology transfer, manufacturing support, and data package generation in line with the overarching drug product development strategy owner by the drug product lead.
- Oversee CDMO execution of studies, development plans, data packages and technical deliverables to ensure alignment with program objectives and functional strategies.
- Review and provide scientific input on study designs, protocols, reports, development recommendations, and investigations to the internal team, receive alignment and effectively communicate to the CDMO.
- Ensure AbbVie readiness for CDMO governance and technical meetings through proactive alignment, issue resolution, and decision preparation.
- Coordinate communication and information flow between CDMOs and internal stakeholders.
- Drive action-item tracking, meeting documentation, risk management, and issue escalation. Ensures organization across documents, meeting minutes, etc.
- Ensures functional alignment on Statements of Work (SOWs), and partners with operations lead on contract signing and execution, shipping logistics, and operational activities.
- Provide technical leadership in the investigation and resolution of issues occurring at external sites in alignment with functional and project strategy.
- Maintain organized project documentation and knowledge management systems within approved AbbVie platforms.
- May support internal programs as drug product lead on CMC cross-functional teams.
Leadership Expectations
- Influence decisions and drive execution across a complex matrix organization without direct authority.
- Build strong partnerships with internal stakeholders and external vendors.
- Anticipate risks and proactively develop mitigation strategies.
- Communicate complex technical information clearly to diverse audiences.
- Represent ABA DPD as a trusted technical leader to CDMOs and cross-functional partners.
- Mentor junior scientists and contribute external development strategies within the function.