Sr Director/Executive Director, Drug Product Development

Jade Biosciences; United States; Remote; USD 255,000 - 300,000; Full time

Job summary

An innovative firm is seeking a strategic Executive Director for Drug Product Development to lead the creation of high concentration biologic drug products. This remote role involves overseeing the development and manufacturing processes, ensuring compliance with regulatory standards, and driving strategic improvements in product design. The ideal candidate will possess a Ph.D. and extensive experience in combination product development, particularly with pre-filled syringes and autoinjectors. Join a dynamic team focused on addressing critical needs in autoimmune diseases and contribute to groundbreaking therapies that can change lives.

Qualifications

• 12+ years of experience in Drug Product Development.
• Experience with high concentration combination products.
• Proven leadership in regulatory compliance.

Responsibilities

• Lead development of biologic drug products and combination products.
• Ensure compliance with FDA and EMA regulations.
• Manage human factors studies for product usability.

Skills

Drug Product Development

Combination Product Development

Regulatory Compliance

Leadership

Formulation Development

Strategic Vision

Problem-Solving

Communication Skills

Education

Ph.D. in Pharmaceutical Sciences

Ph.D. in Biomedical Engineering

Ph.D. in Chemical Engineering

Job description

Sr Director/Executive Director, Drug Product Development

Remote - US

About Jade Biosciences

Jade Biosciences is focused on developing best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead asset, JADE-001, targets the anti-A PRoliferation-Inducing Ligand (APRIL) pathway for immunoglobulin A (IgA) nephropathy, with Investigational New Drug Application-enabling studies underway and initiation of a first-in-human trial expected in the second half of 2025. Jade’s pipeline also includes two undisclosed optimized antibody discovery programs, JADE-002 and JADE-003, currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow us on LinkedIn .

Role Overview

We are seeking a strategic, highly skilled and motivated 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

Combination Product Development

• 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 suitable CDMO partners for combination product manufacturing and provide oversight of development and manufacturing activities.
• 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.

Formulation Development

• Design and develop high concentration biologic dosage forms, ensuring stability, efficacy, and safety.
• Utilize advanced formulation techniques such as spray drying to optimize product performance.
• Conduct research to explore new formulation strategies and technologies that enhance the delivery and stability of biologic drugs.

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

• Sr 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 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 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. Preferred locations are Seattle, San Francisco, Boston or Vancouver B.C.

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 $280,000 - $300,000. 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.

As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster .

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.

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