Intern, Drug Substance Manufacturing - Downstream and Central Services (Wed-Sat 6am-4:30pm)

Position Summary:

ultracurious – Apply your biggest ideas in courageous ways

Our Manufacturing Associates will support Ultragenyx’s Gene Therapy Manufacturing Facility located in Bedford, MA. The Manufacturing Associates will be involved in the Downstream 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.

Work Model: 

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

Responsibilities:

• Attend daily manufacturing tie 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 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 manufacturing areas.
• Demonstrated ability to work with colleagues who represent a diversity of work and conflict resolution styles.
• Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Help to establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
• Practice safe work habits and adhere to safety procedures and guidelines.

Requirements:

• High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience 
• 2-8 years’ experience preferably in pharmaceutical manufacturing or other regulated industry coop and internship experience is considered 
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations. 
• Experience with viral vectors is not required but experience preferred 
• Ability and desire to work in a fast-paced, environment is essential 
• Strong collaboration, team-working skills and communication skills 
• Independently motivated and detail-oriented with good problem-solving ability 
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook) 

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.
• 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).