Principal Research Scientist I - Biologics Drug Product Development
About The Position
AbbVie’s Drug Product Development (DPD) group develops and characterizes drug product formulations and manufacturing processes for biologic therapeutics, including antibodies, antibody-drug conjugates, and novel biologic formats, from preclinical development through clinical proof of concept. The Principal Research Scientist I will join the AbbVie Bay Area (ABA) site in South San Francisco, California, in an on-site role serving as the outsourcing lead for formulation and process development. The position is the primary technical interface between AbbVie and external Contract Development and Manufacturing Organizations (CDMOs), ensuring successful execution of outsourced drug product development. The role drives external execution in partnership with drug product leads, operations specialists, and functional management, aligning strategy, timelines, risks, and deliverables. It also provides technical leadership across internal and external teams and an initial review of CDMO work packages, data, and conclusions.
Requirements
- BS or equivalent education and typically 14 or more years of experience; MS or equivalent education and typically 12 or more years of experience; or PhD and typically 6 or more years of industry experience.
- Strong technical background in formulation principles, drug product degradation pathways, drug product lyophilization and processing, and characterization approaches.
- Experience with design of experiments (DOE) using JMP or Design-Expert.
- Typically 3–5 years leading external development activities at CDMOs, including oversight, method transfer, and technology transfer.
- Demonstrated success resolving investigations with external partners.
- Strong project leadership, stakeholder management, and organizational skills.
- Excellent oral and written communication, negotiation, and influence skills.
- Demonstrated experience leading cross-functional teams without direct authority.
- Ability to manage multiple priorities, drive alignment, and resolve complex technical and operational challenges.
Nice To Haves
- Degree in chemical engineering, pharmaceutical sciences, material science, analytical sciences, or an equivalent field.
- Hands-on experience with analytical techniques used for protein characterization and stability testing, such as SEC, CE-SDS, icIEF, HIAC, MFI, or DLS.
Responsibilities
- Serve as the primary technical liaison between ABA DPD and CDMOs, ensuring functional alignment with management and relevant stakeholders for 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 drug product lead’s overarching development strategy.
- Oversee CDMO 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; obtain internal alignment and communicate effectively with the CDMO.
- Prepare AbbVie for CDMO governance and technical meetings through proactive alignment, issue resolution, and decision preparation.
- Coordinate communication and information flow between CDMOs and internal stakeholders.
- Track action items, document meetings, manage risks, escalate issues, and maintain organized documentation and meeting minutes.
- Ensure functional alignment on Statements of Work (SOWs) and partner with the operations lead on contract signing and execution, shipping logistics, and operational activities.
- Provide technical leadership in investigating and resolving issues at external sites in alignment with functional and project strategy.
- Maintain project documentation and knowledge management systems within approved AbbVie platforms.
- May support internal programs as drug product lead on CMC cross-functional teams.
- 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.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
