Intern, Manufacturing Associate, Upstream, 7:00 AM - 7:00 PM

ultragenyxpharmaceutical; Bedford (MA); Presencial; USD 32.000 - 39.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Generous vacation time and public holl

Volunteer days

Long term incentive

Descripción de la vacante

Ultragenyx's Gene Therapy Manufacturing Facility in Bedford, MA is seeking a Manufacturing Associate Intern to perform cell culture operations from thaw to 2000L bioreactor in a suite/clean room environment. Shift: 7am–7pm with a Pitman 12-hour rotation; on-site work with safety protocols.

The role requires a high school to BS in any field, biotech certificate enrollment, and 1–2 years in a regulated setting; strong math, procedure reading, and MS Office skills are expected.

Formación

• High school degree to BS in any filed. Enrollment in a Biotech Certificate Program.
• Preferably 1-2 years of professional experience in a regulated industry. Experience with cell culture 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.
• Ability to gown and work in clean room environments is a must.

Responsabilidades

• Support the execution of all Upstream manufacturing activities in compliance with environmental health and safety (EHS) requirements, current Good Manufacturing Practices (cGMPs), and Ultragenyx's Standard Operations Procedures (SOPs)/Protocols.
• Responsible for keeping own training curriculum up-to-date, ensuring full training has been taken prior to performing production activities.
• Ensure the cleaning and maintenance of the facility and area equipment.
• Document all work as required by cGMPs on a timely basis
• Perform operations and monitor process with close attention to detail.
• Perform other tasks and projects as assigned by the department manager.

Conocimientos

Attention to detail

Teamwork

Communication

Procedural compliance

Educación

High school diploma

BS degree in any field

Biotech certificate program enrollment

Herramientas

Microsoft Office

Descripción del empleo

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.

Position Summary:

ultra innovative - Tackle rare and dynamic challenges

The Manufacturing Associate Intern will be working within Upstream/Cell Culture Team at Ultragenyx's Gene Therapy Manufacturing Facility in Bedford, MA. The position is a suite/clean room-based position where the Associate will be performing cell culture operations from cell thaw to 2000L Bioreactor.

Shift: 7am to 7pm, Pitman rotation schedule: 12-hour shift position (3 days in, 2 days off, 2 days in, 3 days off) and weekend is required.

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:

• Support the execution of all Upstream manufacturing activities in compliance with environmental health and safety (EHS) requirements, current Good Manufacturing Practices (cGMPs), and Ultragenyx's Standard Operations Procedures (SOPs)/Protocols.
• Responsible for keeping own training curriculum up-to-date, ensuring full training has been taken prior to performing production activities.
• Ensure the cleaning and maintenance of the facility and area equipment.
• Document all work as required by cGMPs on a timely basis
• Perform operations and monitor process with close attention to detail.
• Perform other tasks and projects as assigned by the department manager.

Requirements:

• High school degree to BS in any filed. Enrollment in a Biotech Certificate Program.
• Preferably 1-2 years of professional experience in a regulated industry. Experience with cell culture 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.
• Ability to gown and work in clean room environments is a must.

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 make-up, jewelry, and contact lenses while in the manufacturing environment.

Working in temperature-controlled environments (cold rooms).

*The pay range for this position is $23 - $28/hour.

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.

Pay Range $23 - $28 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 Em