Senior Scientist, Biologics Drug Product development at Ultragenyx in Shoreline Lab, CA

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 required in advance. #LI-CS1 #LI-Onsite

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range$154,700—$191,100 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

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