Intern, Manufacturing Associate, Downstream and Central Services, 6:00 AM - 4:30 PM
Ultragenyx Pharmaceutical
Summary
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.
Job description
Position Summary
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
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 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 downstream and/or solution prep 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
- Able to lift, push, pull up to 50lbs
- Ability to stand for extended periods, climb ladders and stairs
- Ability to work in controlled environment with GxP gowning and PPE
Benefits
- Generous 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.