Associate Director, Biologics Manufacturing Management

Ultragenyx Pharmaceutical · Bedford, MA; Woburn, MA; or Somerville, MA

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<div class="content-intro"><div><strong>Why Join Us?</strong></div> <div> </div> <div><em>Be a hero for our rare disease patients</em></div> <div><em> </em></div> <div>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. </div> <div> </div> <div>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.</div> <div> </div> <div>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<em>. </em></div></div><h3 style="text-align: left;"><strong>Position Summary:</strong></h3> <p style="text-align: left;"><em><strong>ultra</strong>innovative – Tackle rare and dynamic challenges<br></em></p> <p style="text-align: left;"><span class="TextRun SCXW241006323 BCX0" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW241006323 BCX0">You will provide technical </span><span class="NormalTextRun SCXW241006323 BCX0">expertise</span><span class="NormalTextRun SCXW241006323 BCX0"> for </span><span class="NormalTextRun SCXW241006323 BCX0">critical starting materials, drug </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW241006323 BCX0">substance</span><span class="NormalTextRun SCXW241006323 BCX0">, and</span><span class="NormalTextRun SCXW241006323 BCX0">/or</span><span class="NormalTextRun SCXW241006323 BCX0"> drug product </span><span class="NormalTextRun SCXW241006323 BCX0">manufacturing over the life cycle of the products in the Ultragenyx </span><span class="NormalTextRun SCXW241006323 BCX0">b</span><span class="NormalTextRun SCXW241006323 BCX0">iologics</span><span class="NormalTextRun SCXW241006323 BCX0">/gene therapy</span><span class="NormalTextRun SCXW241006323 BCX0"> portfolio</span><span class="NormalTextRun SCXW241006323 BCX0"> from development through commercialization</span><span class="NormalTextRun SCXW241006323 BCX0">. You will serve as </span><span class="NormalTextRun SCXW241006323 BCX0">external manufacturing </span><span class="NormalTextRun SCXW241006323 BCX0">relationship manager</span><span class="NormalTextRun SCXW241006323 BCX0"> at the respe</span><span class="NormalTextRun SCXW241006323 BCX0">ctive contract manufacturing organizations (CMOs) </span><span class="NormalTextRun SCXW241006323 BCX0">and represent </span><span class="NormalTextRun SCXW241006323 BCX0">manufacturing </span><span class="NormalTextRun SCXW241006323 BCX0">as part of</span><span class="NormalTextRun SCXW241006323 BCX0"> cross-functional Ultragenyx CMC teams</span><span class="NormalTextRun SCXW241006323 BCX0">. </span></span><span class="EOP Selected SCXW241006323 BCX0" data-ccp-props="{"201341983":0,"335559738":240,"335559739":120,"335559740":240}"> </span></p> <h3 style="text-align: left;"><strong>Work Model: </strong></h3> <p style="text-align: left;">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.</p> <h3 style="text-align: left;"><strong>Responsibilities:</strong></h3> <ol> <li style="line-height: 2;"><span data-contrast="auto">Oversee external manufacturing of plasmid DNA, biologics and gene therapy drug substance, as well as aseptic drug product manufacturing for biologics and oligonucleotides.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Ensure fulfillment of agreed manufacturing services at CMOs for clinical and commercial supply plans.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Lead relationships with CMOs and foster collaborative partnership.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Participate in Health Authority interactions as a subject matter expert.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Author global CMC filings in accordance with applicable regulations and guidance.  </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Identify and enable selection of DS and DP CMOs, ensure CMO compliance to cGMPs and establish strategic fit.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Actively identify and manage product or manufacturing process risks.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Manage process optimization, tech transfer, and change control.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Drive troubleshooting and quality deviation investigations occurring at manufacturing sites.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Direct key business agreements, manage budget & cost control, approve purchase orders & invoices, and improve COGS development.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ol> <h3 style="text-align: left;"><strong>Requirements:</strong></h3> <ol> <li style="line-height: 2;"><span data-contrast="auto">BS in Pharmaceutical, Biological or Bioengineering Sciences or Engineering.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">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.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">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. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Substantial experience working in an outsourcing model, involving CMO/CDMO management.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Proficient in cGMPs and pharmaceutical industry procedures and regulations.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Good understanding of financial figures, cost management and financial decision making.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Strong collaboration, communication skills and drive for results.  </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Excellent problem-solving skills and verbal/written communication skills.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Ability to support work requirements across multiple Ultragenyx time zones and reflective of 24/7 manufacturing schedules at CMO sites, as applicable.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li style="line-height: 2;"><span data-contrast="auto">Up to 25% travel commitments (domestic and international) and occasional person-in-plant activities.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> </ol> <p><span style="color: rgb(255, 255, 255);"><em>#LI-CT1 </em><em><span class="ui-provider dir dis c d e f g h i j k l m n o p q r s t dit diu w x y z ab ac ae af ag ah ai aj ak">#LI-Hybrid</span></em></span></p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p><em>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.</em></p> <p><em><br>This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.</em></p></div><div class="title">Pay Range</div><div class="pay-range"><span>$179,300</span><span class="divider">—</span><span>$221,400 USD</span></div></div></div><div class="content-conclusion"><div> </div> <div><strong><em>Full Time employees across the globe enjoy a range of benefits, including, but not limited to:</em></strong></div> <div> </div> <div><strong><em>·         Generous vacation time and public holidays observed by the company</em></strong></div> <div><strong><em>·         Volunteer days</em></strong></div> <div><strong><em>·         Long term incentive and Employee stock purchase plans or equivalent offerings</em></strong></div> <div><strong><em>·         Employee wellbeing benefits</em></strong></div> <div><strong><em>·         Fitness reimbursement</em></strong></div> <div><strong><em>·         Tuition sponsoring</em></strong></div> <div><strong><em>·         Professional development plans</em></strong></div> <div> </div> <div><em>* Benefits vary by region and country</em></div> <div> <p><strong>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 </strong><a href="mailto:talentacquisition@ultragenyx.com"><strong>talentacquisition@ultragenyx.com</strong></a><strong>.</strong></p> </div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/CCPA-Notice/"><em>CCPA Employee and Applicant Privacy Notice</em></a><em>.</em></div> <div><em>See our </em><a class="postings-link" href="https://www.ultragenyx.com/privacy-policy/">Privacy Policy</a><em>.</em></div> <div> <p><strong>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.</strong></p> </div> <div><strong>Note to External Recruiters</strong>: 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<em>: </em><a class="postings-link" href="http://mailto:talentacquisition@ultragenyx.com/">talentacquisition@ultragenyx.com</a><em>.</em></div></div>