Senior Scientist/Associate Director, Cell Culture Process Development

Ultragenyx Pharmaceuticals Brisbane , CA 94005

Posted 3 months ago

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, 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 no approved therapies.

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!

Position Summary:

We are seeking a highly motivated senior scientist for cell culture development. The qualified candidate will report to the Director of Cell Culture Process Development in Technical Development group. This position will be responsible for developing/optimizing mammalian cell culture process for enzymes, monoclonal antibodies, growth factors, and other recombinant proteins. Setting up internal capability, managing junior staff, and hands-on activities in upstream technology development are critical aspects of the job. He /she will also support clinical or commercial manufacturing at CMO/CDMO.

Responsibilities, including but not limited to:

  • These may include, but are not limited to, the following; other duties may be assigned

  • Setting up internal development capability from bench scale to pilot scale.

  • Developing high-performance upstream production process in a timely manner.

  • Introducing, developing, and implementing new strategies/technologies to enable accelerated CMC development

  • Supporting tech transfer to CMOs for process scale-up including performing risk assessment and developing appropriate mitigation strategies. Provide PIP support for manufacturing activities and troubleshooting efforts when needed.

  • Participating as a Technical Development representative in cross-functional CMC teams to plan project timelines and meet material supply requirements such as pilot scale Tox run

  • Writing technical summary and development reports for efficient knowledge management and regulatory filing support.

  • Collaborating with downstream, quality control, quality assurance and translational research on development projects.

  • Providing supervision and mentorship to junior scientists or associates

Requirements:

  • Degree in a scientific discipline or equivalent in engineering: PhD with 5-8+ years related experience OR a Masters with 12+ years related experience OR a Bachelors with 15+ years related experience. Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment.

  • Experienced in biological process development and manufacturing experience with a strong record of achievement.

  • Proven track record of accomplishments in the design, development, and implementation of industrial cell culture processes for recombinant protein production

  • Hands-on experience in upstream laboratory activities including the operation of mini/bench to pilot scale bioreactor systems

  • Knowledge of bioreactor characterization and engineering principles as well as robust understanding of biochemistry and cell metabolic pathways is a must. Media development experience is a plus.

  • Demonstrated experience with technology transfer and scale-up to GMP manufacturing facility including providing PIP and trouble-shooting support.

  • Late-stage process development activities including process characterization and control strategy.

  • Demonstrated ability to evaluate and introduce new technologies to accelerate upstream process development and improve process efficiency.

  • Knowledge of CMC regulatory requirements for biological pharmaceutical products at both early and late stages of development

  • Excellent problem solving skills and verbal and written communication skills.

#LI-CV1

Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.


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Senior Scientist/Associate Director, Cell Culture Process Development

Ultragenyx Pharmaceuticals