Principal Research Scientist I - Biologics Drug Product Development

Description

The Drug Product Development group develops and characterizes drug product formulations and manufacturing processes for biologic therapeutics, including antibodies, antibody-drug conjugates, and newer biologic formats, from preclinical work through clinical proof of concept.

This on-site Principal Scientist I role is based in South San Francisco, CA, at the Bay Area site. You will be the outsourcing lead for formulation and process development and the main technical contact between the company and contract development and manufacturing organizations (CDMOs), making sure outsourced drug product work runs well.

You will review CDMO work packages, data, and conclusions first, and act as the group's technical representative. The role works closely with drug product leads, operations specialists, and functional managers on strategy, timelines, risks, and deliverables.

Responsibilities

• Act as the main technical liaison between the group and CDMOs, and keep all external drug product work aligned with management and other stakeholders.
• Lead external work in formulation, process development, technology transfer, manufacturing support, and data package generation, following the overall drug product strategy set by the drug product lead.
• Oversee CDMO studies, development plans, data packages, and technical deliverables so they match program goals and functional strategy.
• Review study designs, protocols, reports, development recommendations, and investigations, get internal sign-off, and pass direction to the CDMO.
• Prepare the company for CDMO governance and technical meetings through early alignment, issue resolution, and decision support.
• Manage information flow between CDMOs and internal teams.
• Track action items, document meetings, manage risks, and escalate issues. Keep documents and meeting minutes organized.
• Align functions on Statements of Work and work with the operations lead on contract signing, execution, shipping logistics, and other operational tasks.
• Provide technical leadership when issues arise at external sites, in line with functional and project strategy.
• Keep project documentation and knowledge systems current on approved platforms.
• You may support internal programs as drug product lead on cross-functional CMC teams.
• Lead across a complex matrix without direct authority, building strong working relationships with internal teams and vendors.
• Spot risks early and build mitigation plans.
• Explain complex technical information clearly to varied audiences.
• Serve as a trusted technical leader to CDMOs and cross-functional partners.
• Mentor junior scientists and help shape external development strategy in the group.

Requirements

• BS or equivalent education with extensive experience, typically 14+ years; MS or equivalent with typically 12+ years; or PhD with typically 6+ years of industry experience.
• A PhD in chemical engineering, pharmaceutical sciences, materials science, analytical sciences, or a related field is highly preferred.
• Solid technical grounding in formulation principles, drug product degradation pathways, lyophilization and processing, and characterization approaches, including design of experiments using JMP or Design Expert.
• 3-5 years leading external development work at a CDMO, including oversight, method transfer, and technology transfer, with a record of resolving investigations with external partners.
• Hands-on experience with protein characterization and stability methods such as SEC, CE-SDS, icIEF, HIAC, MFI, and DLS is preferred.
• Strong project leadership, stakeholder management, and organization skills.
• Clear written and spoken communication, plus skill in negotiation and influence.
• Proven experience leading cross-functional teams without direct authority.
• Ability to juggle multiple priorities, build alignment, and solve complex technical and operational problems.

Conditions

On-site role in South San Francisco, CA.

The base pay range is the company's good-faith estimate at posting based on the job grade. Actual pay within the range depends on factors including geographic location, and may fall above or below it. The range may change over time.

The role is eligible for long-term incentive programs.

Bonuses, incentives, benefits, and other compensation are at the company's sole discretion unless paid, and may change within the law. Pay is not earned until it is vested and determinable.

Open to applicants in the US and Puerto Rico only. The company is an equal opportunity employer and welcomes applicants regardless of veteran or disability status.

Benefits

• Paid time off covering vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) plan for eligible employees.
• Eligibility for long-term incentive programs.