Manufacturing Associate II- Drug Substance Upstream - Gene Therapy

Position Summary:

ultrafocused - Work together to fearlessly uncover new possibilities

The Manufacturing Associate II will be working within the Upstream Team at Ultragenyx's Gene Therapy Manufacturing Facility in Bedford, MA. The position is a suite/cleanroom-based position where the Associate II will be performing cell culture operations from cell thaw to 2000L Bioreactor. This is a 12-hour rotation shift position (3 days in, 2 days off, 2 days in, 3 days off) and every other weekend is required.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

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 Good Documentation Practices (GDPs) on a timely basis

• Perform operations and monitor process with close attention to detail.

• Create, write and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks.

• Perform other tasks and projects as assigned by the department manager.

Requirements:

• High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience.

• 2+ years' experience preferably in pharmaceutical manufacturing or other regulated industry. Coop and internship experience is considered.

• Experience working with viral vectors and/or Biological processes is highly desirable.

• Ability to accurately perform arithmetic calculations including fractions, decimals, percentages and basic algebra.

• Ability to read, understand, and follow procedures.

• Be computer proficient, especially with Microsoft Office (Word, Outlook, Excel).

• Ability and desire to work in a fast-paced, start-up environment is essential

• Strong collaboration, team-working and communication skills is required.

• Detail-oriented and independently motivated is a must.

• Ability to gown and work in clean room environments is a must.

• General knowledge of and adherence to cGMPs.

Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping / bending / kneeling

• Able to lift, push, pull up to 50lbs.

• 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 complete and pass a vision exam to verify clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors with or without correction. #LI-CS1 #LI-Onsite