Basel, SwitzerlandUltragenyx – Technical OperationsFull-timeApply for this job Why Join Us? Be a hero for our rare disease patients Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives. Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include remote based web-ex video discussions, interviews & onboarding.
Who We’re looking for? Generous and Candid. You treat everyone with respect and communicate broadly and often - providing clear purpose, context, necessary information, candid feedback and business insights that helps to propel your colleagues and stakeholders forward. Courageous and Drive Results. You are resilient, resourceful, roll up your sleeves, and challenge the status quo. You are a servant leader - passionate about our patients, the business, never compromising relationships. Relentless, Culture and Patient Focused. You are driven by a deep commitment to delivering treatment to our patients. You are relentless about making a difference to patients and their families. Dynamic and Fiercely Collaborative. You are a catalyst for innovation, you partner closely with your peers to drive CMC partnership activities, and you’re invested in others' success. You're purposefully inclusive and are a role model for stakeholder management. Creative and See Possibility. You think strategically and explore multiple ways to deliver unique value to the business. You are known not only for your skills of diagnosing organizational needs, but more importantly you have great ideas and you can influence action to be taken that address those needs. You are someone who thrives in the building and creation stage of an organization—taking your insights to action.
Position Summary ultracurious – Apply your biggest ideas in courageous ways We are seeking a highly motivated and experienced biopharmaceutical operations leader to support CMC development and manufacturing for Ultragenyx’s small molecule products as well as synthetic components integrated into other product platforms. Ultragenyx currently has small molecule projects at the pre-clinical and clinical phases of development. The role will require leadership skills including CMC partnership, manufacturing, and CMO relationship management of various projects. Additionally, the ideal candidate should be willing to learn and develop new areas of expertise and skill to support biologics development and manufacturing. This position will report to the Senior Director, Chemical & Pharmaceutical Manufacturing, and interact with several other CMC quality & regulatory functions in Ultragenyx and at CMOs, in addition to supply chain management, translational research, technical development, and clinical teams within the company.
Responsibilities, including but not limited to:
Lead small molecule external manufacturing, especially drug substance manufacturing, in a cGMP environment.
Lead production planning, execution, and tracking. Ensure fulfillment of agreed manufacturing services for clinical and commercial supply.
Manage CMO relationships and foster collaborative partnerships. Lead and/or contribute to CMO selection and onboarding.
Support and/or lead CMC projects of Ultragenyx´s small molecule portfolio. Author and/or provide inputs to CMC sections in support global regulatory filings.
Be an integral part of cross-functional and cross-discipline CMC teams for products that include synthetic components.
Develop and maintain CMC manufacturing activities, QTPP (Quality Target Product Profile), Product Design History File and Quality Risk Management Plan.
Drive required components of the CMC strategy to accomplish CMC team goals.
Manage process development and optimization technology transfer as well as production related change control, deviation, and complaint.
Drive RFPs, SOWs, MSAs, and other governance documents.
Promote and implement knowledge management processes for appropriate sharing and storage of documentation.
Provide strong representation on global projects and in functional and cross-functional teams.
Skills and Experience
Preferably Ph.D. (minimum Master's Degree) in chemistry, chemical engineering, organic chemistry or related discipline with deep understanding of industry scale small molecule synthetic chemistry and demonstrable expertise in pharmaceutical CMC development, process scale-up and cGMP manufacturing and supply chain management.
10+ years of relevant experience in small and/or large biopharmaceutical companies, and working in global organizations.
Proven accomplishments and experience in cGMP manufacturing, external manufacturing, and working in a highly matrixed organization.
Track record with ability to build and sustain effective CMO partnerships.
Ability and experience to contribute to regulatory filing processes including INDs, IMPDs, NDAs, MAAs, and other regulatory related documents.
Experience with analytical development and quality control is an advantage.
Experienced in development and clinical manufacturing of small molecule drug substance as well as commercial launch and manufacturing. Drug product manufacturing experience in various dosage forms is a plus.
Demonstrated experience with participation in and/or leading CMC teams and executing CMC activities.
Cross-functional experience a plus; willingness and ability to develop and learn.
Ability to work with business systems and processes including legal, finance, quality, as well as manufacturing and supply chain operations.
Good understanding of financial figures, cost management, and financial decision making.
Experience in continuous improvement, operational and business process excellence projects.
Excellent problem-solving skills as well as verbal and written communication skills in English are required. Skills in additional languages such as German are strongly welcomed.
Travel approximately 25%
This position is based in Allschwil, Switzerland and valid work permit for Switzerland is required.
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Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.
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