Sr. Director/Executive Director, Drug Product Development

Jade Biosciences; United States; Remote; USD 255,000 - 310,000; Full time

Job summary

A biotechnology company is seeking a Sr. Director/Executive Director of Drug Product Development to lead efforts in developing high concentration biologic drug products. This remote role requires substantial experience in biologic combination product development, strategic leadership, and oversight of regulatory compliance. The anticipated salary range is $255,000 – $310,000, depending on experience and qualifications.

Qualifications

• 12+ years of experience in Drug Product Development for Director role.
• 15+ years of experience in Drug Product Development for Executive Director role.
• Proven executive leadership in development processes.

Responsibilities

• Champion development of combination product presentation.
• Manage execution of human factors studies.
• Develop strategic vision for dosage presentation changes.

Skills

Leadership

Regulatory compliance

Strategic vision

Problem-solving

Education

Ph.D. in Pharmaceutical Sciences or related field

Job description

Overview

Remote

About Jade Biosciences

Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead candidate, JADE101, is designed to inhibit the cytokine APRIL (A Proliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN), a chronic kidney disease that can impair kidney function over time. JADE101 aims to reduce harmful IgA antibodies, lower proteinuria (a key marker of kidney damage), and preserve long-term kidney function. A Phase 1 healthy-volunteer study of JADE101 is ongoing, with interim, biomarker-rich data expected in the first half of 2026. Jade’s pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both currently in preclinical development. For more information, visit JadeBiosciences.com and follow us on LinkedIn.

Role Overview

We are seeking a strategic, highly skilled and motivated Sr. Director/Executive Director of Drug Product Development to join our dynamic team. The successful candidate will lead our efforts in the development and manufacturing of high concentration biologic drug products, with pre-filled syringes and autoinjectors intended as the final product presentation. The ideal candidate will be experienced in setting strategic direction and hands-on leadership of the development and manufacturing of biologic combination products. This position requires a deep understanding of technical and regulatory aspects of combination product development, including drug product formulation and fill/finish process, primary container development, stability, combination product design, verification, and validation, and assembly, labeling, and packaging processes.

Key Responsibilities

• Champion the development of the target combination product presentation (pre-filled syringe / autoinjector). Collaborate with internal and external resources to achieve a combination product presentation suitable for patient use.
• Ensure rigorous design verification and validation studies are planned to meet all functional and safety criteria set by regulatory guidance from FDA, EMA and ROW.
• Manage the execution of human factors studies to evaluate the usability of combination products, focusing on enhancing user experience and safety.
• Leveraging the analysis of study results to drive strategic improvements in product design and functionality.

Drug Product Manufacturing Oversight

• Identify and Manage CDMO partners for drug in vial and combination product manufacturing
• Provide oversight of development and manufacturing activities from Phase 1 through to Phase 3/Commercial.
• Provide oversight of late-stage drug product development activities through to PPQ commercial supply readiness.
• Ensure implementation of robust quality control measures by CDMO partners to assure product quality, integrity, stability and compliance throughout the manufacturing process.
• Coordinate and facilitate technology transfer and ensure seamless integration of new products into production lines.

Strategic Leadership and Vision

• Develop and execute the strategic vision for dosage presentation changes from vial to combination product, aligning development with business needs, patient standard of care, and industry trends.
• Collaborate with external partners and internal functions to integrate and align Drug Product development activities around strategic clinical development goals

Late-Stage Process Validation Leadership

• Lead the design and execution of studies supporting process validation for combination products, ensuring robust and scalable manufacturing processes for commercial production.

Regulatory and Compliance

• Ensure all development activities adhere to relevant regulatory guidelines.
• Lead the preparation and maintenance of comprehensive documentation for regulatory submissions and audits.

Qualifications

• Director: Ph.D., or equivalent in Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, or a related field with 12+ years of experience in Drug Product Development with emphasis on high concentration biologic combination product development, particularly with pre-filled syringes and autoinjectors.
• Executive Director: Ph.D., or equivalent in Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, or a related field with 15+ years of experience in Drug Product Development with emphasis on high concentration biologic combination product development, particularly with pre-filled syringes and autoinjectors.
• Proven executive leadership in development processes and regulatory compliance for combination products.
• Experienced in leading combination product development workstreams, including primary container evaluation, contract manufacturer identification, engagement, and oversight, combination product platform technology evaluation, design control process, design verification studies, design validation, and human factors engineering.
• Demonstrated success in managing late-stage process validation studies.
• Exceptional strategic vision, problem-solving skills, and leadership capabilities.
• Strong executive communication and collaboration skills.

Position Location

This is a remote role; periodic travel to team and company events is required.

Compensation

The anticipated salary range for candidates for this role at the Sr Director level is $255,000 – $280,000 and at the Executive Director level is $280-$310,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Equality and Compliance

As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.