Associate Director, Biologics Manufacturing Management at Ultragenyx in Somerville, MA

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:

ultrainnovative – 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 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.

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

Oversee external manufacturing of biologics drug substance manufacturing and aseptic drug product manufacturing for biologics and oligonucleotides.
Support Biologics CMC strategy, milestones and goals with input from the key stakeholders, such as the CMC Review Forum and gaining approval from the Program Core Team and the respective functional management.
Ensure fulfillment of agreed manufacturing services at CMOs for clinical and commercial supply plans.
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.
Lead relationships with CMOs and foster collaborative partnership.
Own relevant purchase orders, invoices, and contracts to support external expense activities.
Participate in Health Authority interactions as a subject matter expert.
Actively identify and manage product or manufacturing process risks.
Support contract negotiation with CMOs to ensure sustainable supply and partnership.
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 experience in Process Development, MSAT or Manufacturing in biotech / pharmaceutical industry. Fewer years are acceptable if combined with relevant advanced degree.
Technical experience in launch and commercial bioprocess manufacturing, including one or more of plasmid DNA, upstream drug substance, downstream drug substance, or drug product manufacturing.
Substantial experience working in an outsourcing model, involving CMO/CDMO management.
Experienced in both late-stage development and manufacturing/launching of complex biologic modalities such as Plasmid DNA, Monoclonal Antibodies, Enzymes, or RNA based medicines.
Experience in CMC and product development teams.
Cross-functional experience in Quality Assurance, Regulatory Affairs, R&D are desirable.
Proficient in cGMPs and pharmaceutical industry procedures and regulations.
Good understanding of financial figures, cost management and financial decision making.
Strong Project management skills.
Strong collaboration, communication skills and drive for results.
Excellent problem-solving skills and verbal/written communication skills.
Passionate about helping patients and collaboratively working in a diverse environment.
Ability to support work requirements across multiple 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.

Physical Demand Requirements:

Stand for extended periods of time with periodic stooping / bending / kneeling
Able to lift, push, pull up to 50lbs.
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.
Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment. #LI-CS1 #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$168,600—$208,200 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.

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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.