Principal Research Scientist I - Biologics Drug Product Development

Posted Yesterday
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South San Francisco, CA, USA
Hybrid
125K-237K Annually
Expert/Leader
Healthtech • Pharmaceutical
The Role
Leads outsourced biologics drug product formulation and process development through CDMOs. Serves as the primary technical liaison, overseeing studies, technology transfer, manufacturing support, data packages, investigations, risk management, governance, and technical deliverables. Partners with internal cross-functional teams and external vendors to align strategy, resolve issues, manage documentation, and ensure compliant execution. Provides technical leadership, influences decisions across matrix organizations, mentors scientists, and may lead internal drug product development programs.
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Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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.

Qualifications

  • 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. 

Additional Information

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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Skills Required

  • BS or equivalent education with typically 14+ years of experience
  • MS or equivalent education with typically 12+ years of experience
  • PhD or equivalent education with typically 6+ years of industry experience
  • Degree in chemical engineering, pharmaceutical sciences, material science, analytical sciences, or equivalent field
  • Strong technical background in formulation principles, drug product degradation pathways, lyophilization, and processing
  • Deep understanding of characterization approaches and design of experiments using JMP or Design-Expert
  • 3–5 years leading external development activities at CDMOs, including oversight, method transfer, and technology transfer
  • Demonstrated success resolving investigations with external partners
  • Hands-on experience with protein characterization and stability-testing techniques, such as SEC, CE-SDS, icIEF, HIAC, MFI, and DLS
  • Strong project leadership, stakeholder management, and organizational skills
  • Excellent oral and written communication, negotiation, and influencing skills
  • Experience leading cross-functional teams without direct authority
  • Ability to manage multiple priorities, drive alignment, and resolve complex technical and operational challenges

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support — Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support — Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth — Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

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The Company
HQ: North Chicago, IL
56,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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