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

The role

You will support the downstream and central services manufacturing processes at a gene therapy facility in Bedford, MA. You will help write and review standard operating procedures and batch records, and support quality investigations and continuous improvement.

What you will do

• Attend daily manufacturing tier 1 meetings and report current operation status.
• Generate, review and approve SOPs, batch records and protocols for downstream and central services manufacturing.
• Support quality investigations, continuous improvement and engineering activities in the manufacturing areas.
• Ensure maintenance, upkeep and organization of the facility and processes in downstream and central services areas.
• Support all activities in compliance with environmental health and safety requirements and cGMPs.

Required qualifications

• High school degree to BS in any field, or enrollment in a Biotech Certificate Program.
• Ability to perform arithmetic calculations, including fractions, decimals, percentages and basic algebra.
• Ability to read, understand and follow procedures.
• Computer proficiency, especially 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.
• Stand for extended periods with periodic stooping, bending and kneeling.
• Lift, push and pull up to 50 lbs.
• Climb ladders and stairs of various heights.
• Work in a controlled environment with GxP gowning and protective clothing; remove make-up, jewelry and contact lenses in the manufacturing environment.

Nice to have

• 1-2 years of professional experience in a regulated industry.
• Experience with downstream and/or solution prep.

Benefits

• 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.

Before you apply

• Medical clearance is required in advance for tasks that may require a respirator.
• Requires gowning and protective clothing for a controlled manufacturing environment.

About the company

Ultragenyx Pharmaceutical is a biopharma company focused on rare disease medicine, with multiple gene therapy programs in development. The company describes itself as an equal opportunity employer.