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Watershed Therapeutics · 1 hour ago

Director of Product Development (Head of R&D)

Bellevue, WA

Full-time

Onsite

Director/Executive

10+ years exp

Watershed Therapeutics is building a platform for long-residence, intravesical drug delivery that changes how urologists treat chronic bladder disease. They are seeking a Director of Product Development to serve as the Head of R&D, responsible for driving the scientific roadmap and overseeing product development from formulation to clinical execution.

BiotechnologyHealth CareMedicalPharmaceutical

No H1B

Responsibilities

Build and lead the internal R&D organization, including the recruitment and mentorship of senior scientists and technical staff

Serve as the lead architect for our solid dosage forms and complex delivery systems, ensuring scalability from bench to clinic

Provide direct technical oversight for Analytical Development and Device Engineering. You will ensure these functions are synchronized with formulation efforts to support a seamless drug-device combination strategy

Own the external manufacturing strategy. You will identify, contract, and manage CDMOs, negotiating Master Service Agreements (MSAs) and Quality Agreements to ensure GMP readiness

Maintain a strong physical presence in the lab. You will review raw data, troubleshoot experimental anomalies, and personally oversee critical prototype fabrication

Partner with regulatory service providers to define the CMC strategy for 505(b)(2) submissions and ensure all development work meets Design Control and GMP standards

Manage the R&D budget and ensure technical execution aligns with investor milestones and clinical timelines

Qualification

PhD in Pharmaceutical SciencesSolid Dosage FormsDrug-device combination productsAnalytical method validationDevice design controlsCDMO managementLeadershipHands-on technical leadership

Required

PhD in Pharmaceutical Sciences is required

10+ years of industry experience in pharmaceutical product development

Deep expertise in Solid Dosage Forms (granulation, tableting, extrusion) is mandatory

Proven track record of developing drug-device combination products through late phase development

Strong working knowledge of analytical method validation and device design controls

Demonstrated success in selecting and managing CDMOs for early-phase clinical manufacturing (Phase 1/2)

A 'doer' who leads from the front. You must be comfortable working in a fast-paced, resource-constrained startup environment without a large administrative support structure

Must be currently based in the Greater Seattle area