Ascendis Pharma

Redwood City, California, United StatesProduct Development, US Product DevelopmentFull time
Description
In this position you will be responsible for aspects of development, characterization, scale up, and transfer of the manufacturing process for our localized delivery technology platform. Reporting to the director of process development, this position requires an independent and creative thinker able to work with internal and external groups in support of process development and manufacturing objectives.
· Designs and oversees experiments in support of characterizing and validating the process for clinical and commercial implementation of Ascendis’ platform products.
· Support process efforts at CMO’s for GLP and GMP manufacture of development products focusing on hydrogel production, drug loading, formulation, freeze-thaw and filling.
· Assist in the design and testing of custom and standard equipment for implementation in GLP/GMP processes (eg reactor design, novel separation equipment, process trains)
· Support R&D terminal sterilization work
· Work with analytical team to assist in the development and optimization of in process and characterization/release assays
· Generation of material in the lab as needed for in vitro and in vivo studies, assay development, etc
· Assist in the authoring of CMC regulatory filings and health authority interactions
· Foster collaborations across Ascendis sites in Europe and the US to provide development support to projects in all therapeutic areas
· Work on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implement strategic policies when selecting methods and techniques
· Establish and assure adherence to budgets, schedules, work plans, and performance requirements.
· Other responsibilities as required according to corporate strategy or group needs; including supervising Research Associates
Requirements
· Bachelor’s degree in Chemical Engineering, Chemistry, Biochemistry, Materials science or related field
· Minimum Bachelors plus 6 years of experience in the Biotech or Pharmaceutical Industry, preferably in Process Development / Manufacturing Science and Technology / Formulation or Analytical Development, Masters with 3 years, or PhD with relevant experience
· Experience with aseptic processing, e.g. drug delivery solutions, ADC’s or polymer conjugates, novel technologies, hydrogels preferred
· Strong hands-on expertise in process optimization, characterization and development
· Knowledge in cGMP, regulatory and quality requirements of tech transfer/ parenteral drug manufacturing
· Experience with terminal sterilization preferred
· Experience in equipment design preferred (tanks, fittings, custom assemblies, disposables, typical biotechnology processing equipment) a plus
· technology transfer support
· Prior experience working with CMOs preferred
· General knowledge of polymer-based drug delivery preferred, including handling of highly potent drugs preferred
· Pro-active, collaborator and communicator, with a solid understanding of drug development and an ability to plan and conduct work with little guidance
· Strong team player with an open mindset, that thrives in global collaborations
· Ability to travel up to 10% of the time domestically and internationally preferred
New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law
BenefitsMedical insuranceVision insuranceDental insurance401(k)Paid maternity leavePaid paternity leaveCommuter benefitsDisability insurance
Job Type: Full-time