Associate Director, Biologics Manufacturing Management

Associate Director, Biologics Manufacturing Management at Ultragenyx Associate Director, Biologics Manufacturing Management at Ultragenyx in Somerville, Massachusetts Posted in about 14 hours ago.

Type:

Full Time Job Description:

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:

ultra innovative - Tackle rare and dynamic challenges You will provide technical expertise for critical starting materials, drug substance, and/or drug product manufacturing over the life cycle of the products in the Ultragenyx biologics/gene therapy portfolio from development through commercialization. You will serve as external manufacturing relationship manager at the respective contract manufacturing organizations (CMOs) and represent manufacturing as part of cross-functional Ultragenyx CMC teams.

Work Model:

Flex:

This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

Oversee external manufacturing of plasmid DNA, biologics and gene therapy drug substance, as well as aseptic drug product manufacturing for biologics and oligonucleotides. Ensure fulfillment of agreed manufacturing services at CMOs for clinical and commercial supply plans. Lead relationships with CMOs and foster collaborative partnership. Participate in Health Authority interactions as a subject matter expert. Author global CMC filings in accordance with applicable regulations and guidance. Identify and enable selection of DS and DP CMOs, ensure CMO compliance to cGMPs and establish strategic fit. Actively identify and manage product or manufacturing process risks. Manage process optimization, tech transfer, and change control. Drive troubleshooting and quality deviation investigations occurring at manufacturing sites. Direct key business agreements, manage budget & cost control, approve purchase orders & invoices, and improve COGS development.

Requirements:

BS in Pharmaceutical, Biological or Bioengineering Sciences or Engineering. 10+ years of relevant combined experience in Process Development, MSAT, Quality Assurance, or Manufacturing in biotech / pharmaceutical industry. Fewer years are acceptable if combined with relevant advanced degree. Technical experience in process development and commercial bioprocess manufacturing, including one or more of plasmid DNA, enzymes, antibodies, gene therapies, or aseptic drug product manufacturing. Substantial experience working in an outsourcing model, involving

CMO/CDMO

management. Proficient in cGMPs and pharmaceutical industry procedures and regulations. Good understanding of financial figures, cost management and financial decision making. Strong collaboration, communication skills and drive for results. Excellent problem-solving skills and verbal/written communication skills. Ability to support work requirements across multiple Ultragenyx time zones and reflective of 24/7 manufacturing schedules at CMO sites, as applicable. Up to 25% travel commitments (domestic and international) and occasional person-in-plant activities. #LI-CT1 #LI-Hybrid 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$179,300—$221,400 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 . 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 : . VEVRAA Federal Contractor. We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state. PDN-a1d45c2f-6479-46a7-a7f0-27881c7d280b