Research Scientist/Engineer Senior

University of Washington•Seattle, WA

About The Position

The Research Scientist/Engineer Senior leads CMC development strategy and operational execution to advance the Institute for Protein Design’s computationally designed proteins and nanoparticle vaccines from discovery toward preclinical development and clinical use. The role coordinates development plans, timelines, milestones, budgets, risk assessments, technology transfer, and external manufacturing partners in collaboration with the Core R&D Lead for Process Development, principal investigators, translational scientists, trainees, and the project management team. It evaluates candidates for development potential, supports Target Product Profile development, prepares Lead Candidate Selection and Preclinical Development packages, and builds and manages a network of contract development and manufacturing organizations and other vendors. As the portfolio matures, the role may oversee CMC activities required to deliver cGMP clinical test materials for Phase 1 trials. The position has institute-wide impact by establishing development plans and manufacturing partnerships that help IPD discoveries progress toward preclinical development, licensure, partnering, and clinical use. It supports programs funded by philanthropic and federal sources and industry collaborations, and provides a CMC and manufacturing foundation for outlicensing, partnering, and spinout activities. The position reports to the Director of Translational Research, with a dotted-line relationship to IPD Leadership and principal investigators.

Requirements

Ph.D. in biochemistry, bioengineering, chemical engineering, or a related field, and 7 years of experience in a related field; equivalent education and/or experience may substitute where permitted.
Extensive CMC development and operations experience, including working knowledge of process development, formulation, and analytical characterization.
Demonstrated experience leading production-process technology transfer to cGMP facilities or CDMOs.
Demonstrated experience bringing a biologic to Phase 1 trials, including oversight of Drug Substance and Drug Product manufacture and release.
Experience managing 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, and ability to work 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, and HPLC.
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 principal investigators, the Director of Translational Research, and the Project Management team.
Assess manufacturability of research-stage candidates and provide feedback to design and translational teams to improve developability.
Work with in vivo core scientists to provide design input and support preclinical studies informing Lead Candidate Selection.
Prepare Lead Candidate Selection packages focused on preclinical readiness, manufacturability, and cost of goods, and prepare 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 other vendors, coordinating technical packages, partner onboarding, contracts, and timelines.
Select, conduct due diligence on, develop, and manage development and manufacturing partners, maintaining direct working relationships.
Engage CRO/CDMO partners to develop and manufacture protein constructs, incorporating IPD trainees at appropriate levels of involvement.
Oversee external partners’ work against scope, budget, timelines, and quality expectations.
Support legal and contractual agreements for external development and manufacturing partners in coordination with IPD teams and UW offices.
Coordinate and manage authoring of regulatory filings, contributing CMC strategy and programmatic sections with scientific leads, regulatory advisors, and faculty.
Author regulatory filings and supporting documents, including CMC/Module 3 sections for IND-enabling and regulatory submissions.
Work with IPD Leadership and regulatory and translational advisors to define regulatory strategy for candidate advancement.
With the Core R&D Lead for Process Development, implement and maintain stage-appropriate quality standards, including GLP- and GMP-aligned practices, SOPs, batch records, and certificates of testing.
Evaluate 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 standardized systems, such as worksheets and databases, to capture candidate information including names, sequences, and performance.
Build and share repeatable development best practices across the Institute.
Contribute as needed to reports, grant applications, and materials for external partners and funders.