Job description

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. • BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of industry experience is required (in chemical engineering, pharmaceutical sciences, material science, analytical sciences, or equivalent field, is highly preferred). • Strong technical background in formulation principles, drug product degradation pathways, drug product lyophilization and processing, and deep understanding of characterization approaches, DOE using JMP/Design Expert. • 3-5 years leading external development activities at CDMO including but not limited to oversight, method and tech transfer; demonstrated success in resolving investigations with external partners. • Hands-on experience in analytical techniques used for protein characterization and stability testing preferred (e.g., SEC, CE-SDS, icIEF, HIAC, MFI, DLS, etc.). • Strong project leadership, stakeholder management, and organizational skills. • Excellent communication (oral and written), 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. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. • This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit abbvie.com US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: abbvie.com

Requirements

Must-haves

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.
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.
Strong technical background in formulation principles, drug product degradation pathways, drug product lyophilization and processing, and deep understanding of characterization approaches, DOE using JMP/Design Expert.
3-5 years leading external development activities at CDMO including but not limited to oversight, method and tech transfer; demonstrated success in resolving investigations with external partners.
Strong project leadership, stakeholder management, and organizational skills.
Excellent communication (oral and written), 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

Hands-on experience in analytical techniques used for protein characterization and stability testing preferred (e.g., SEC, CE-SDS, icIEF, HIAC, MFI, DLS, etc.).

Application prep

Use the role’s language and application details while tailoring your materials.

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Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

401(K)

Paid Time Off