Intern, Manufacturing Associate, Upstream, 7:00 AM - 7:00 PM
Ultragenyx Pharmaceutical
Summary
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.
Job description
Position Summary
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.
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 field. 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).
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 cell culture is preferred
- Ability to accurately perform arithmetic calculations including fractions, decimals, percentages and basic algebra
- Ability to read, understand, and follow procedures
- Computer proficient, especially in Microsoft Office (Word, Outlook, Excel)
- Ability and desire to work in a fast-paced, start-up environment
- Strong collaboration, teamwork and communication skills
- Detail-oriented and independently motivated
- General knowledge of and adherence to cGMPs
- Ability to gown and work in clean room environments
- Ability to stand for extended periods, stoop, bend, kneel
- Able to lift, push, pull up to 50lbs
- Climb ladders and stairs of various heights
- Ability to work in a controlled environment requiring GxP gowning and protective clothing
- May require use of a respirator with medical clearance
- Must remove all make-up, jewelry, and contact lenses in manufacturing environment
- Ability to work in temperature-controlled environments (cold rooms)
Benefits
- Vacation Time
- Public Holidays
- Volunteer Days
- Long-Term Incentive Plans
- Employee Stock Purchase Plans
- Employee Wellbeing Benefits
- Fitness Reimbursement
- Tuition Sponsorship
- Professional Development Plans
- Annual Bonus
- Equity Incentives
Company overview
Ultragenyx Pharmaceutical Inc. is a pioneering biopharmaceutical company dedicated to developing and commercializing novel therapies for serious rare and ultra-rare genetic diseases. Founded in 2010 by Dr. Emil D. Kakkis, the company is headquartered in Novato, California and operates globally with a presence in North America, Europe, Asia, and Latin America. Ultragenyx has built a diverse portfolio of approved medicines including Crysvita® for X-linked hypophosphatemia, Mepsevii® for mucopolysaccharidosis type VII, Dojolvi® for long-chain fatty acid oxidation disorders, and Evkeeza® for homozygous familial hypercholesterolemia. The company employs multiple therapeutic modalities including biologics, small molecules, gene therapies, and antisense oligonucleotides to address diseases with high unmet medical needs. With over 1,000 employees and a robust clinical pipeline, Ultragenyx maintains one of the most extensive rare disease development programs in the industry, focusing on metabolic disorders, bone diseases, enzyme deficiencies, and neurological conditions. The company is publicly traded on NASDAQ under the symbol RARE and continues to advance its mission of delivering transformative treatments to patients with limited or no therapeutic options.