Senior Director – Drug Product Development

October 23

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

+1 more states

🏄 California – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

💵 $255k - $310k / year

⏰ Full Time

🟠 Senior

👔 Director

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Jade Biosciences

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Biotechnology • Pharmaceuticals

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

11 - 50 employees

Founded 2024

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• 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. • 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. • 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. • Lead the design and execution of studies supporting process validation for combination products, ensuring robust and scalable manufacturing processes for commercial production. • Ensure all development activities adhere to relevant regulatory guidelines. • Lead the preparation and maintenance of comprehensive documentation for regulatory submissions and audits.

🎯 Requirements

• 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.