Senior Scientist, Small Molecule 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:

ultrafocused – Work together to fearlessly uncover new possibilities

We are seeking a highly motivated and experienced individual to lead formulation and process development for Ultragenyx's small molecule and antisense oligonucleotide drug products. This position will report to the Senior Director of Process Development, and represent drug product development function in CMC development teams to enable successful regulatory filings of new products.

Work Model:

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

Responsibilities:

• Work independently to develop drug product formulations and manufacturing processes for Ultragenyx's small molecule and antisense oligonucleotide products.
• Conduct process optimization, scale-up, tech transfer, process characterization, and validation activities.
• Collaborate with other functional areas in the CMC project team to deliver project milestones on time and within budget.
• Work with CDMOs and manage their activities to ensure timely delivery of high quality work.
• Author relevant sections in regulatory filings and address agency questions (IND, IMPD, NDA).
• Support Manufacturing Management and Quality functions in deviation investigations and product life cycle management.
• Provide formulation support for projects in non-clinical development stage as appropriate.
• Follow all safety and compliance regulations and company policies at work.

Requirements:

• A degree in 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
• Hands-on experience in formulation and process development for solid oral dosage and/or parenteral drug products.
• Working knowledge of quality and regulatory requirements of small molecule and ASO products including ICH guidelines.
• Excellent problem-solving skills and verbal and written communication skills.
• Experience in DOE statistical approach in formulation and process development.
• Experience working with contract manufacturing organizations is preferred.
• Experience in pediatric formulations development is desired.

Physical Demand Requirements:

• 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

  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 reimburs