Associate Scientist Process Development

Ascendis Pharma Redwood City , CA 94065

Posted 2 weeks ago

Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to support your personal development on our journey towards becoming a leading rare disease company.

Ascendis Pharma is looking for an experienced Associate Scientist, Process Development to join our team. This is an exciting opportunity to join a rapidly growing, innovative company!

Position Summary

In this position, the Associate Scientist, will be responsible for conducting laboratory experiments related to the development, characterization, scale up of a manufacturing process for our localized delivery technology platform. Working closely with a team of scientists and engineers in our new Redwood Shores facility, the Associate Scientist will characterize and investigate novel and existing processing steps used to manufacture products in our growing portfolio. This position offers great potential for growth of scientific and drug development experience while working on exciting, complex, and impactful products

Key Responsibilities

  • Conduct characterization experiments to investigate critical parameters for various processing steps: eg mixing, filtration, tangential flow processes, formulation steps, lyophilization, sieving filling, freezing etc.
  • Support scale-up of processes, instruments and equipment from the laboratory through pilot plant and manufacturing.
  • Investigate and develop in process methods and equipment to monitor unique process attributes
  • Evaluate various laboratory equipment and processing strategies
  • Troubleshoot process and equipment
  • Support contract manufacturing activities
  • Collaborate with the global Ascendis research team in efforts to acquire product and process knowledge of the platform technology, and transfer this knowledge to new labs
  • Plan and manage key elements in the commissioning of the processing labs for localized delivery and oncology
  • Generate R&D material in the lab for assay and development use as needed
  • Work with analytical team to assist in the development and optimization of formulation and lyophilization parameters, selection of primary containers, and product assays
  • Assist in reports and sections of regulatory filings
  • Creation of standard procedures for equipment and process
  • Other responsibilities as required according to corporate strategy or group needs
  • Ability to travel domestically and internationally Approximately 5% of time

Requirements

  • Bachelors/Masters degree in chemical engineering, chemistry, biochemistry, or a related field with 1 to 4 yrs experience in industry is preferred
  • Hands-on experience in a laboratory setting
  • Experience in the biotech or pharmaceutical Industry, preferably in process development / manufacturing science and technology / formulation or analytical
  • Basic knowledge of process parameters used for standard operations: mixing filtration, purification, filling etc.
  • Pro-active collaborator and communicator, with an 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
  • Preferred experience:
    • drug delivery, ADCs or polymer conjugates, novel technologies, hydrogels, aseptic processing
  • knowledge of experience in cGMP, requirements of pharmaceutical processing
  • equipment design (tanks, fittings, custom assemblies, typical biotechnology processing equipment)
  • Prior experience working with CMOs
  • General knowledge of polymer-based drug delivery
  • Experience with highly potent material handling

Benefits

  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Paid maternity leave
  • Paid paternity leave
  • Commuter benefits
  • Disability insurance
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Associate Scientist Process Development

Ascendis Pharma