Director, Quality Control Stability
3 weeks ago
Why Join Us?Be a hero for our rare disease patientsAt 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 possibilitiesThe Director of QC Stability is responsible for maintaining and continuously improving our stability program to support our AAV gene therapy products. The stability program covers all product stages (Cell Bank, Viral Bank, Plasmid, Drug Substance and Drug Product) at both clinical and commercial development stages to support shelf life and meet global regulatory expectations. This key individual will author stability plans/protocols, maintain stability tables, perform trend analysis, and propose/support shelf-life extensions. As stability is a critical aspect of regulatory filings, this individual will author stability sections for clinical and commercial health authority submissions (IND/IMPD/BLA/MAA).The Director of QC Stability will lead a team of 3-4 scientists and interact with multiple groups in the QC lab, CMC, Analytical Development, Quality, IT, and Manufacturing. This is a core role (minimum 4 days on site) at our QC lab in Woburn, MA.Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.Responsibilities:Maintain and continuously improve the Stability Program for efficiency and compliance.Collaborate with CMC teams to define strategy.Author stability plans/protocolsMaintain stability data, perform trend analysis, and author reports.Maintain on-site stability chambers and samples.Utilize LIMS to set up studies, schedule pulls, and organize data.Author CMC stability sections of Heath authority submissions (clinical and commercial).Support HA inspections, briefing book prep, and information requests.Own Quality system records as needed (deviation, change controls, CAPA).Utilize risk management principles in program design.Develop new processes as needed, such as shelf-life extension processes.Requirements:BS or MS in Biochemistry, Biology, Chemistry, or related discipline with 10+ years relevant industry experienceDirect experience in biologics or gene therapy stability department.Experience in regulatory section authoring and global regulatory requirements is required.Experience in managing direct reports (5+ years)Experience drafting protocols, data reports and QC/QA compliance documents required.Flexibility and adaptability to prioritize and pivot based on business needs.Excellent technical writing skillsExperience in data management and lab informatic systems.Demonstrated ability to lead strategically and implement systems and solutions.Independently motivated and detail-oriented with good problem solving ability. #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 reimbursement•Tuition sponsoring•Professional development plans* Benefits vary by region and countryUltragenyx 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.comSee our CCPA Employee and Applicant Privacy Notice.See our Privacy Policy.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.
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