Senior Scientist, Biologics Drug Product Development

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

In this role, you will be responsible for formulation, scale-up, technology transfer and supporting process development activities for Ultragenyx's growing biologic pipeline that require parenteral dosage form development. You will work with internal groups as well as with network of external vendors to manage formulation and drug product development activities. You will contribute to the Drug Product/Formulation function in CMC development teams to enable successful regulatory filings of new biologics.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

 

Responsibilities:

• Represent formulation and drug product function in internal and external CMC teams
• Design and perform lab-based experiments and activities to develop drug product formulations and manufacturing processes for Ultragenyx’s biologics products
• Work with CRO and CDMO in managing various aspects of the drug product development
• Design and conduct drug product process optimization including lyophilization, characterization, and clinical compatibility studies
• Author relevant drug product sections in regulatory filings and address agency questions
• Provide formulation and molecule support for Translational Research projects as appropriate
• Document laboratory experiments and results in lab notebooks and summarize findings in technical reports as needed
• Follow all safety and compliance regulations and company policies at work

Requirements:

• A degree in Biochemistry, Chemistry, Chemical Engineering, Bioengineering, Pharmaceutical Sciences or a related discipline
• PhD with 5-8 years, MS with 8-10 years, or BS with 10-12 years industry working experience. Job title is dependent on candidate’s experience level.
• Must have hands-on experience in formulation and DP process development for biologics
• Familiar with fill-finish processes, lyophilization development, clinical compatibility studies, scale-up and/or technology transfer
• Experience working with contract manufacturing and testing organizations is preferred
• Must have knowledge of analytical instrumentation used in biologics formulation development such as spectrometry, HPLC, CE, particle characterization techniques (HIAC, MFI, NTA), spectrometry, calorimetry, light scattering etc.
• Requires working knowledge of regulatory filings (IND/IMPD, BLA, MAA, being familiar with quality and regulatory requirements
• Experience in DOE statistical approach in formulation and process development is desired
• Experience in both early stage and late-stage process development is desired
• Must have excellent problem-solving skills and verbal and written communication skills

Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping/bending / kneeling.
• Able to lift, push, pull up to 50lbs.
• Climb ladders and stairs of various heights.
• Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment.
• Certain tasks may require use of a respirator; medical clearance will be