Job Description
The Department of Biochemistry Institute for Protein Design's (IPD) has an outstanding opportunity for a Research Scientist/Engineer Senior to join their team.
About this Opportunity
This position reports to the Director of Translational Research, with a dotted-line relationship to IPD Leadership and PIs.
The Sr. Manager, CMC Development & Operations leads the transition of the Institute for Protein Design's (IPD) computationally designed proteins and nanoparticle vaccines from discovery into development. This position leads the CMC development and operational execution that move a designed protein or nanoparticle vaccine from discovery into development, encompassing CMC development strategy, program and timeline management, technology transfer coordination, and the operational management of external manufacturing partners. Partnering with the IPD's Core R&D Lead for Process Development, who executes bench-side process development and technology transfer, the CMC Development & Operations role coordinates the development plan, sequencing/timeline, and external execution and vendor management.
Working closely with IPD Principal Investigators (PIs), translational scientists, trainees, and the IPD Project Management team, this role serves as the Institutes programmatic owner of the CMC development pathway and its operations, and leads preclinical and translational timelines, sequencing, and milestones across the portfolio. The role evaluates candidates for development potential, prepares Lead Candidate Selection and Preclinical Development packages, supports the development of functional Target Product Profiles (TPPs), and grows and manages the Institute's network of contract development and manufacturing organizations (CDMOs) from selection and due diligence through ongoing project execution.
This position anchors the discovery-to-development bridge for IPD's therapeutic and vaccine programs. As the Institute's development portfolio matures, the role is also positioned to oversee all CMC related activities required for delivery of cGMP clinical test materials to supply Phase 1 trials.
Purpose of the research project(s):
This position has institute-wide impact by directly enabling IPD's designed proteins and vaccines to progress toward preclinical development, licensure, partnering, and clinical use. By establishing rigorous, well-sequenced development plans and a trusted manufacturing partner network, the Sr. Manager increases the likelihood that IPD's discoveries reach real-world impact.
The role shapes the developability of IPD's translational portfolio - including programs supported by philanthropic funders such as the Gates Foundation, federal center grants, and industry collaborations - and provides the CMC and manufacturing foundation on which the Institute's outlicensing, partnering, and spinout activities depend. Effective performance directly supports the University of Washington's research and translational mission by de-risking candidates, strengthening funding and partnering positions, and building the Institute's capacity to develop its own molecules.
Key Responsibilities
CMC Development Strategy & Candidate Advancement (45%)
- Own the CMC development strategy and sequencing for designed protein therapeutics and nanoparticle vaccine candidates, coordinating with the Core R&D Lead for Process Development to integrate process development and tech-transfer work.
- Work closely with PIs, Director of Translational Research, and Project Management team to support integrated development timelines, development milestones, associated budgets, risk assessments, and go/no-go decision points across the translation portfolio.
- Assess the manufacturability of research-stage candidates and provide feedback to design and translational teams to improve developability.
- Work closely with IPD in vivo core scientists to provide design input and support for preclinical in vivo studies that inform Lead Candidate Selection.
- Prepare comprehensive Lead Candidate Selection packages, with emphasis on preclinical readiness, manufacturability, and cost of goods.
- Prepare Preclinical Development packages to advance nanoparticle vaccine and protein therapeutic candidates.
- Support the development of functional Target Product Profiles (TPPs) for vaccine and therapeutic candidates.
Manufacturing & Partner Management (25%)
- Manage technology transfer to external CDMOs or other vendors, coordinating the scientific lead's technical package with partner onboarding, contracts, and timelines.
- Select, conduct due diligence on, develop, and manage a network of trusted development and manufacturing partners, maintaining ongoing, direct working relationships.
- Engage CRO/CDMO partners as needed to develop and manufacture protein constructs,incorporating IPD trainees at their chosen level of involvement, from consulting-only to fully embedded.
- Oversee external partners' execution against scope, budget, timelines, and quality expectations.
- Support the establishment and maintenance of the legal and contractual agreements required for interactions and studies with external development and manufacturing partners, in coordination with IPD Grants team, IPD Project Management team, and UW offices.
Regulatory, Quality & CMC Documentation (20%)
- Coordinate and manage the authoring of regulatory filings, contributing CMC-strategy and programmatic sections in partnership with the scientific leads, regulatory advisors, and IPD 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 advancing candidates.
- In partnership with Core R&D Lead for Process Development, implement and maintain quality standards appropriate to each stage of development, including GLP- and GMP-aligned practices, SOPs, batch records, and certificates of testing.
Discovery-to-Development Translation and Infrastructure (10%)
- Evaluate therapeutic and vaccine candidates for Lead Candidate potential against yield, preclinical data, manufacturability, and IP/FTO criteria.
- Engage and collaborate with graduate students and postdoctoral scientists on advancing candidates and preparing them for future use (e.g., outlicensing, internal or external development, etc.).
- Design and maintain systems, such as structured worksheets and databases, for capturing critical candidate information (e.g., names, sequences, performance) in a standardized way.
- Build and share repeatable development best practices across the Institute.
- As needed, contribute to reports, grant applications, and materials required for external partners and funders.
Required Qualifications
To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
Minimum Qualifications
Ph.D. in biochemistry, bioengineering, chemical engineering, or related field and 7 years of experience in related field.
Additional Qualifications:
- Extensive CMC development and operations experience, with 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.
- Proven 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 the ability to build and motivate teams in a positive, collaborative environment without direct oversight.
- Strong project management, organizational, and communication skills, with the ability to work effectively across scientific, technical, and business interfaces.
Preferred Qualifications:
- 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 (e.g., 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.
Compensation, Benefits and Position Details
Pay Range Minimum:
$150,000.00 annual
Pay Range Maximum:
$175,008.00 annual
Other Compensation:
-
Benefits:
For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
Shift:
First Shift (United States of America)
Temporary or Regular?
This is a regular position
FTE (Full-Time Equivalent):
100.00%
Union/Bargaining Unit:
Not Applicable
