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Manufacturing Associate II - Upstream - Day Shift (Pitman schedule)
ultragenyxpharmaceuticalBedford3d ago
- Seniority
- Junior
About the role
<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;"> </h3>
<p> </p>
<h3 style="text-align: left;"><strong>Position Summary:</strong></h3>
<p style="text-align: left;"><strong><em>ultra</em></strong><em>focused – Work together to fearlessly uncover new possibilities</em></p>
<p><span data-contrast="auto">The Manufacturing Associate II will be a suite-based position within the Gene Therapy Manufacturing facility. The position is a suite/clean room-based position where the Associate II position will be an on the floor technician assigned to the Upstream Manufacturing area. </span><span data-ccp-props="{"201341983":0,"335559740":256}"> </span></p>
<p><span data-contrast="auto">Expertise will include all cell thaw and culture activities through the various scale of bioreactors up to 2000L and harvest operations.</span><span data-ccp-props="{"201341983":0,"335559740":256}"> </span></p>
<p><span data-contrast="auto">The position is scheduled from 7am to 7pm on a Pitman rotation. </span></p>
<h3 style="text-align: left;"><strong>Work Model: </strong></h3>
<p style="text-align: left;">Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.</p>
<h3 style="text-align: left;"><strong>Responsibilities:</strong></h3>
<ol>
<li style="line-height: 2;"><span data-contrast="auto">Ongoing maintenance of own training file ensuring full training has taken place for all aspects of the production activities in the GTMF area.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Overseeing and driving their training in the GTMF area to enable them to carry out their duties efficiently and compliantly.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Be able to operate efficiently the Veeva Vault system for all quality documentation.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Ensure that high standards of cGMP are adhered to at all times.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Revise GMP documents and templates including batch records, SOPs, OJTs and logbooks.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Ensure that high standards of cGMP documentation completion are adhered to at all times and documentation is left in a reviewable condition at all times.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Demonstrate ownership of the process to ensure that all resources (materials, personnel, documentation etc.) required for processing are available.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Strive to become a subject matter expert for all “assigned” equipment in the area of control.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Identification of immediate actions/escalation needed to mitigate risk to product, employee safety, or schedule as appropriate.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Identify any Continuous Improvements to the process/equipment and drive through to completion any projects to which may be assigned.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Ensure high standards of housekeeping are adhered to at all times.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Participate in internal/regulatory audits as required.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Attend projects and other meetings as required.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Ensure effective liaison and communication with other departments, maintaining good relations at all times.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Ensure that objectives given are met in the appropriate agreed timescale.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
</ol>
<h3 style="text-align: left;"><strong>Requirements:</strong></h3>
<ol>
<li style="line-height: 2;"><span data-contrast="auto">High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">2+ years’ experience preferably in pharmaceutical manufacturing or other regulated industry coop, and internship experience is considered.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Experience with viral vectors and/or biological processes.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Strong collaboration, teamwork skills, and communication skills.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Ability and desire to work in a fast-paced, start-up environment is essential.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Independently motivated and detail-oriented with good problem-solving ability.</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":200,"335559740":276}"> </span></li>
<li style="line-height: 2;"><span data-contrast="auto">Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":200,"335559740":276}"> </span></li>
</ol>
<p><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":200,"335559740":276}"><span style="font-size: 12pt;"><strong><span class="TextRun SCXW266528191 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW266528191 BCX8">Physical Demand Requirements</span></span><span class="EOP SCXW266528191 BCX8" data-ccp-props="{"201341983":0,"335559739":0,"335559740":256}"> </span></strong></span></span></p>
<p><strong><span data-contrast="auto">General Manufacturing: Drug Substance/Central Svcs:</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":256}"> </span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Stand for extended periods of time with periodic stooping / bending / kneeling</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Able to lift, push, pull up to 50lbs.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Climb ladders and stairs of various heights.</span><span data-ccp-props="{"201341983":0,"335559739":200,"335559740":276}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Certain tasks may require the use of a respirator; medical clearance will be required in advance.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="36" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Working in temperature-controlled environments (cold rooms).</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":276}"> </span></li>
</ul>
<h3 style="text-align: left;"> </h3><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>$78,300</span><span class="divider">—</span><span>$96,700 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>
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- Equity Compensation
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