Research Scientist/Engineer Senior

University of Washington•Seattle, WA

2d•$150,000 - $175,008

About The Position

The University of Washington Department of Biochemistry Institute for Protein Design (IPD) is hiring a Research Scientist/Engineer Senior to lead CMC development strategy and operational execution for computationally designed proteins and nanoparticle vaccines as they move from discovery into development. The role coordinates development plans, sequencing, timelines, technology transfer, and external manufacturing partners in collaboration with the Core R&D Lead for Process Development, who leads bench-side process development and technology transfer execution. Working with IPD Principal Investigators, translational scientists, trainees, and the Project Management team, the position owns the programmatic CMC development pathway and operations. It leads preclinical and translational timelines, milestones, candidate evaluation, Lead Candidate Selection and Preclinical Development packages, and development of functional Target Product Profiles. It also builds and manages a network of contract development and manufacturing organizations (CDMOs), from selection and due diligence through project execution. The position bridges discovery and development for IPD therapeutic and vaccine programs. As the portfolio matures, it may oversee CMC activities needed to deliver cGMP clinical test materials for Phase 1 trials. Its institute-wide impact includes establishing development plans and manufacturing partnerships that help advance IPD discoveries toward preclinical development, licensure, partnering, and clinical use. The position reports to the Director of Translational Research, with a dotted-line relationship to IPD Leadership and PIs.

Requirements

Ph.D. in biochemistry, bioengineering, chemical engineering, or a related field, and 7 years of experience in a related field.
Extensive CMC development and operations experience, including working knowledge of process development, formulation, and analytical characterization.
Demonstrated experience leading technology transfer of production processes to cGMP facilities or CDMOs.
Demonstrated experience bringing a biologic to Phase 1 trials, including overseeing Drug Substance and Drug Product manufacture and release.
Demonstrated program and operations management of CMC/development timelines, budgets, and external vendors across multiple candidates or programs.
Experience managing CDMO, CRO, and supplier relationships across multiple sites and vendors, from contract negotiation through ongoing project management.
Experience preparing CMC sections of regulatory filings and supporting documentation.
People-management experience and ability to build and motivate teams in a positive, collaborative environment without direct oversight.
Strong project management, organizational, and communication skills, including the ability to work effectively across scientific, technical, and business interfaces.

Nice To Haves

Master's or Bachelor's degree with equivalent relevant industry experience.
Experience with protein therapeutics and/or nanoparticle vaccine candidates.
Familiarity with analytical characterization approaches such as SEC-MALS, DLS, HPLC, and related methods.
Experience as a technical program, operations, or alliance manager in a biotech, CDMO, or translational research setting.
Experience developing Lead Candidate Selection packages and Product Development packages.
Experience in an academic or nonprofit translational research setting.
Familiarity with IP and technology transfer, including developability and freedom-to-operate considerations.
Project Management Professional (PMP) certification or equivalent.

Responsibilities

Own CMC development strategy and sequencing for designed protein therapeutics and nanoparticle vaccine candidates, coordinating with the Core R&D Lead for Process Development.
Coordinate integrated development timelines, milestones, budgets, risk assessments, and go/no-go decisions with PIs, the Director of Translational Research, and the Project Management team.
Assess candidate manufacturability and advise design and translational teams on developability.
Work with IPD in vivo core scientists to provide design input and support for preclinical studies informing Lead Candidate Selection.
Prepare Lead Candidate Selection packages emphasizing preclinical readiness, manufacturability, and cost of goods, as well as Preclinical Development packages for vaccine and protein therapeutic candidates.
Support development of functional Target Product Profiles for vaccine and therapeutic candidates.
Manage technology transfer to external CDMOs and vendors, coordinating technical packages, partner onboarding, contracts, and timelines.
Select, conduct due diligence on, develop, and manage development and manufacturing partners and ongoing working relationships.
Engage CRO/CDMO partners to develop and manufacture protein constructs, with IPD trainees involved at an appropriate level.
Oversee external partners' performance against scope, budget, timelines, and quality expectations.
Support legal and contractual agreements for external development and manufacturing work with the IPD Grants team, IPD Project Management team, and UW offices.
Coordinate regulatory filing authorship and contribute CMC strategy and programmatic sections with scientific leads, regulatory advisors, and IPD faculty.
Author regulatory filings and supporting documents, including CMC/Module 3 sections for IND-enabling and other regulatory submissions.
Work with IPD Leadership and regulatory and translational advisors to define candidate regulatory strategy.
Partner with the Core R&D Lead for Process Development to implement and maintain development-stage-appropriate quality standards, including GLP- and GMP-aligned practices, SOPs, batch records, and certificates of testing.
Evaluate therapeutic and vaccine candidates for Lead Candidate potential based on yield, preclinical data, manufacturability, and IP/FTO criteria.
Collaborate with graduate students and postdoctoral scientists to advance candidates and prepare them for future use, including outlicensing or internal or external development.
Design and maintain systems such as standardized worksheets and databases for critical candidate information.
Build and share repeatable development best practices across the Institute.
Contribute as needed to reports, grant applications, and materials for external partners and funders.