Senior Scientist, Drug Product and Formulation 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: ultracurious – Apply your biggest ideas in courageous ways Looking for a highly motivated individual who has strong passion for science and pharmaceutical development, particularly for drug product and formulation development, as well as downstream process and clinical in-use activities. The ideal candidate will demonstrate curiosity and commitment to understanding the product lifecycle from preclinical formulation to manufacturing, and end-user product handling and administration. A drive for independent and cross-functional learning and collaboration is essential for this role. The role may involve direct management of team members and the cross-functional team. Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. Responsibilities: Lead development and optimization of drug product processes for gene therapy products, including chromatography, ultrafiltration/diafiltration, formulation, mixing, filtration, filling, and freeze/thaw operations. Lead drug product (DP) process, formulation, characterization and clinical device development studies. Apply hands-on downstream development skills in the laboratory, designing and executing laboratory experiments, result analysis, documentation and presentations. Author and review technical protocols, study reports, investigation and scientific presentations, and generate, evaluate, and maintain data in a highly organized manner. Design and execute chromatography and purification experiments as necessary for formulation development, investigation, DP manual fill and finish for DP vial studies. Support the characterization of drug product manufacturing processes, including gap analysis, risk assessment, control strategy and investigation studies. Lead or support process parameter robustness study including impact analysis, studies of formulation and excipient impact on freezing, thawing, mixing, hold-time, filtering, filling and product contact on DP. Execute container characterization studies including primary container safety (extractables & leachables (E&L)) and impact analysis on product stability. Perform clinical device compatibility studies (Drug product with infusion sets, syringes, diluents). Support design and help with executing studies associated with drug product formulation stability, degradation pathway, container/closure compatibility, drug product hold-time, shipping, and handling robustness. Perform activities on developing formulation appropriate for various clinical administration methods (e.g., IV, SC, ICM, intrathecal), especially for novel modalities. Design, select, evaluate, and risk assess delivery devices (syringe pumps, catheters, IV sets, filters, etc.) and ancillary supplies by working with vendors and manufacturers. Support clinical readiness by developing or integrating rapid analytical tools (e.g., endotoxin testing, AAV genome titers, particulate matters, aggregation). Familiarity with ICH, ISO and FDA guidelines, CMC documentations including protocols, reports, and regulatory requirements for IND, IMPD, BLA/MAA. Requirements: PhD or Master’s degree in Chemical or Biochemical Engineering, Biochemistry, Biology, Chemistry, Pharmaceutical, Pharmacy or related discipline. 5-8 years (PhD), 8+ years (Masters) relevant industry experience in drug product and formulation development. Hands-on pharmaceutical experience with drug product development for injectable therapeutics, including formulation process unit operations such as TFF, mixing, DS and DP filtration, DP filling and freezing / thawing. Hands-on experience of scale-up, tech transfer, and process characterization principles of the drug product manufacturing process at prior pharmaceutical companies. Experience with drug product container closure systems and clinical device compatibility and safety including extractable and leachable. Familiarity with hands-on or at least solid knowledge in formulation and drug product analytics, such as: subvisible particle analysis, viscosity, turbidity, dynamic light scattering, UV, A260/A280, Bilayer interferometry, differential scanning fluorometry, Size exclusion-HPLC, qPCR and mass photometry, and mass spectroscopy a plus. Knowledge of process development for upstream and downstream purification, including ability to run chromatography using AKTA and Unicorn systems. Excellent communication and documentation skills, and ability to work effectively, follow-through in a collaborative team environment, including close collaboration with MSAT, AD, QC and clinical development/operation. Demonstrate team spirit and collaboration, sharing resources, while being cognizant of roles, responsibilities and timelines of program needs. Individuals are independent, motivated, detail oriented and have good problem-solving ability. #LI-KJ1 #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 $160,300—$198,000 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. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.