Director, CMC Project Management

November 4

🏄 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

💵 $210k - $235k / year

⏰ Full Time

🔴 Lead

👷‍♀️ Project Manager

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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

• In collaboration with the CMC team members, facilitate management of the CMC activities for our drug development programs, ensuring they are completed on time, within budget, and according to company goals • Work closely with CMC quality assurance and CMC regulatory to ensure effective collaboration and execution of CMC deliverables • Maintain integrated CMC development plans across our candidate programs and pro-actively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs • Collaborate with cross-functional program managers to effectively communicate CMC activities and ensure alignment with overall program goals and timelines • Track program risks, proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success • Manage relationships with external partners, vendors, and contractors as required to ensure smooth program execution • Support development and refinement of processes, tools and systems to deliver high quality PM support to the CMC programs

🎯 Requirements

• Bachelor's degree in a related field required; advanced degree preferred • 15+ years of experience in CMC program management within the biotech or pharmaceutical industry • PMP certification preferred • Strong experience in providing program management to CMC teams while interacting with cross-functional teams • Knowledge and understanding of CMC early-stage development pathways, including cell line development, drug substance and drug product manufacturing processes, analytical, formulation and stability studies • Preferred knowledge and understanding of CMC late-stage development including process characterization, process and method validation, tech transfers and comparability studies. Additionally, experience in managing programs for combination products is also desired. • Excellent organizational skills and ability to forward-plan • Proven track record of successful project management of complex drug development programs in a fast-paced startup environment • Expertise with project management tools (e.g. Smartsheet, Microsoft Timeline Pro+) • Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment • Proactively identifies issues and drives resolution; can anticipate key future events and adjust team priorities/plans accordingly • Excellent communication and interpersonal skills with the ability to influence and motivate cross-functional teams, manage a diverse set of stakeholders, and work closely with team leaders • Strong written and oral communication skills with strong attention to detail.