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Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Responsibilities
• Partner with Clinical Supply Chain Planning Lead to monitor the production and distribution strategies for their respective programs
• Serve as Supply Chain Execution point of contact with internal stakeholders (i.e. Supply Chain, QA, Clinical Operations)
• Provide oversight to Denali’s Finished Product supply chain vendors and facilitate execution activities (i.e. Contracts, Product Set Up, Labeling, Packaging, Distribution, Inventory Management)
• Facilitate Label development, approval, and tracking
• Facilitate QP Declaration and Certification issuance and tracking
• Document and execute IRT transactions required to facilitate the release and distribution of product through the clinical supply chain
• Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure
• Proactively identify and troubleshoot issues to prevent missed timelines
• Communicate status of supply execution activities both verbally and through written documents and reports
• Drive continuous operational performance improvement efforts
• Participate in supply chain business process development projects
Requirements
• Bachelor’s degree in Industrial Engineering/Operations/Supply Chain or related field
• 3+ years experience in clinical supply chain management or manufacturing in the Life Sciences.
• Experience in vendor oversight and managing external partnerships and relations is preferred
• Experience working on cross functional projects and business process definition/improvements is preferred
• Knowledge of IRT system setup and functionality is preferred
• Demonstrated ability to work accurately, meet timelines and handle multiple priorities
• Skilled in using influence management to drive project success
• Capable of responding flexibly to changing prioritization in a dynamic environment
• Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner
• Strong verbal and written communication skills
• Proficiency in MS Excel, Word, and PowerPoint
• Requires working knowledge of cGMP and regulations applicable to the FDA and comparable international regulatory agencies.
Salary Range: $131,000 to $162,333. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers.
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
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https://www.denalitherapeutics.com/denali-applicant-privacy-policy
