Manufacturing Associate III (Drug Substance) - shift work 2:00PM

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:

ultrafocused – Work together to fearlessly uncover new possibilities

The Manufacturing Associate will be a key member of the Drug Substance Manufacturing team responsible for the on-the-floor operations at our Gene Therapy Manufacturing Facility. The Manufacturing Associate will be ensuring GMP compliance as well as writing SOPs and batch records to support plant operations. Must be detail-oriented with troubleshooting abilities. You will be expected to be knowledgeable in purification operations (chromatography, TFF, Viral Filtration, Membrane Filtration) and single-use disposable technology.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site on a shift basis 2:00PM - 10:30PM.

Responsibilities:

Ensure high standards of cGMP are always adhered to.
Must be able to efficiently operate the Veeva Vault system for all quality documentation, Deviations, Change Controls and CAPA systems.
Develop, write, and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks.
Drive to closure the manufacturing review of the completed batch records in a timely manner per established targets.
Ensure high standards of cGMP documentation completion are always adhered to.
Demonstrate a thorough and complete understanding of safety requirements, and GMP compliance of the plant and process.
An Operational Excellence champion - driving medium level continuous improvements to the process or systems.
Represents manufacturing in Project team meetings as required.

Requirements:

Typically requires a university degree and a minimum 4 years of related experience,
2 yr degree with 6+ yrs, or
No degree with 8+ years
GMP manufacturing experience preferably in pharmaceutical manufacturing.
Strong collaboration, teamwork, and communication skills
Independently motivated and detail-oriented with good problem-solving ability.
Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

Physical Demand Requirements:

General Manufacturing: Drug Substance:

Stand for extended periods of time with periodic stopping / bending / kneeling
Able to lift, push, pull up to 50lbs.
Climb ladders and stairs of various heights.
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.
Certain tasks may require the use of a respirator; medical clearance will be required in advance.
Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.
Working in temperature-controlled environments (cold rooms).

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$86,000—$106,300 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.