Intern, Manufacturing Associate, Downstream and Central Services, 6:00 AM - 4:30 PM

Ultragenyx; Bedford (MA); Presencial; USD 34.000 - 41.000; Jornada completa

Descripción de la vacante

Ultragenyx in Bedford, MA is seeking Manufacturing Associates to support state-of-the-art GMP manufacturing for gene therapy. The role involves downstream and central services, creating SOPs and batch records, and maintaining a compliant, efficient production area.

Candidates should be detail-oriented, able to work on a fast-paced startup environment, with 1–2 years in a regulated industry preferred, and proficiency in Microsoft Office. The shift is Tuesday–Friday, 6am–4:30pm, on site.

Formación

• High school degree to BS in any field; enrollment in Biotech Certificate Program.
• Preferably 1–2 years in a regulated industry.
• Ability to read, understand, and follow procedures; proficient in Microsoft Office.
• Able to work in a fast-paced, startup environment with strong collaboration.
• Detail-oriented and independently motivated; knowledge of cGMPs is a plus.

Responsabilidades

• Attend daily manufacturing tier 1 meetings and communicate operation status.
• Generate, review, and approve SOPs, batch records, and protocols for Downstream and Central Services.
• Support quality investigations and continuous improvement tied to manufacturing areas.
• Maintain facility organization and uptime in Downstream/Central Services.
• Follow environmental health and safety and cGMP requirements.

Conocimientos

Teamwork

Communication skills

Attention to detail

Self-motivation

MS Office proficiency

Ability to read procedures

Educación

High school to BS in any field

Biotech certificate program enrollment

Herramientas

Filtration techniques

Tangential flow filtration

Column chromatography

Aseptic technique

Descripción del empleo

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.

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.

Position Summary:

ultra focused - Work together to fearlessly uncover new possibilities

Ultragenyx has multiple Gene Therapy programs in development in the rare and ultrarare disease space, a robust pipeline. Our Manufacturing Associates will support Ultragenyx’s state-of-the-art GMP manufacturing gene therapy manufacturing facility located in Bedford, MA. The Manufacturing Associates will be involved in the Downstream and central services manufacturing processing responsibilities. The role may require you to write standard operating procedures and batch records to support plant operations. The ideal candidate must be detail-oriented with troubleshooting abilities. You will be expected to be knowledgeable in General filtration, tangential flow filtration, column chromatography, and aseptic technique.

Shift: Tuesday-Friday, 6am to 4:30pm

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Attend daily manufacturing tier 1 meetings and be prepared to communicate current operation status.
• Generates / Reviews / Approves new and current SOP’s, batch records, and/or protocols in support of the equipment and manufacturing processes associated with the Downstream and Central Services manufacturing areas.
• Supports quality investigations, continuous improvement efforts and engineering activities as they directly impact the functionality of the manufacturing areas.
• Ensure maintenance, upkeep, and organization, of the facility and processes within the Downstream and central services manufacturing areas.
• Demonstrated ability to work with colleagues who represent a diversity of work and conflict resolution styles.
• Support the execution of all activities in compliance with environmental health and safety (EHS) requirements, and good manufacturing procedures (cGMPs)

Requirements:

• High school degree to BS in any field. Enrollment in a Biotech Certificate Program.
• Preferably 1-2 years of professional experience in a regulated industry. Experience with downstream and/or solution prep is not required but experience is preferred.
• Ability to accurately perform arithmetic calculations including fractions, decimals, percentages and basic algebra.
• Ability to read, understand, and follow procedures. Be computer proficient, especially in Microsoft Office (Word, Outlook, Excel).
• Ability and desire to work in a fast-paced, start-up environment is essential
• Strong collaboration, teamwork and communication skills
• Detail-oriented and independently motivated is a must.
• General knowledge of and adherence to cGMPs.

General Manufacturing: Drug Substance/Central Svcs:

• Stand for extended periods of time with periodic stooping / 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 makeup, jewelry, and contact lenses while in the manufacturing environment.
• Working in temperature-controlled environments (cold rooms).
• The pay range for this position is $25 - $30/hour.

#Onsite

Onsite Salary Information

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

$25 - $30 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

Equal Opportunity Statement

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 [e-mail].

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