Sr Associate Process Development

Role Summary

Sr Associate Process Development

Responsibilities

• Setup, execute, monitor, and troubleshoot cell culture, harvest, and purification operations up to the 500L pilot plant scale utilizing such equipment as rocking and single-use bioreactors, and single-use chromatography and filtration systems (TFF, VF, UFDF).
• Perform in-process sampling and prepare buffers/media per defined manufacturing procedures as needed.
• Pack and qualify chromatography columns up to 40 cm in diameter.
• Document work in electronic lab notebooks per GDP principles while following appropriate SOPs.
• Generate, analyze, and summarize process data to identify and mitigate challenges to future commercial processes, and support new technology development, new product introductions, and facility tech transfers.
• Write, review & revise documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc).
• Use digital tools such as Biovia Workbook, Emerson DeltaV, PI Vision, Smartsheet, Spotfire, Tableau, and the Microsoft suite (Outlook, Word, Excel, PowerPoint, Visio, SharePoint, Teams).
• Maintaining an organized and clean workspace.
• Identifying, recommending, and implementing improvements related to routine functions
• Performing activities that include periods of rigorous, repetitive work.
• Working safely around high-pressure systems and heavy equipment.

Qualifications

• Basic Qualifications:
  • High school diploma / GED and 6 years of Scientific experience OR
  • Associate‚Äôs degree and 4 years of Scientific experience OR
  • Bachelor‚Äôs degree and 2 years of Scientific experience OR
  • Master‚Äôs degree
• Preferred Qualifications:
  • Application of process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to everyday tasks.
  • Adherence to all regulatory requirements, written procedures, policies, and safety guidelines at all times.
  • Ability to organize work, handle multiple priorities, and meet deadlines.
  • Ability to interpret and apply GDP, FAIR, and ALCOA+ principles to everyday work.
  • Identify, recommend, and implement improvements related to routine functions (facilitate the drive towards continuous improvement in the plant).
  • Maintain an organized and clean workspace. Contributes to general housekeeping and 5S initiatives.
  • Demonstrates a sense of ownership and pride in work performed.
  • Demonstrate the Amgen Values and contribute to a culture of safety.
  • Ability to work in teams to complete operational tasks in a timely manner.
  • Creates a positive work environment through interactions with team members.
  • Ability to take initiative, follow up, ask questions and always act with honesty and integrity.
  • Ability to regularly lift up to 35 lbs, push and pull objects that require up to 50 lbs of force, and work on your feet for long durations.
  • Ability to perform physical movements to perform daily tasks on the production floor such as bending, reaching above the head, climbing, kneeling, squatting, stooping, walking up or down stairs, and standing on portable stairs or ladders up to 6 feet off the ground.
  • Ability to work some off-hours and weekends due to the nature of the work.

Education

• Not specified beyond Basic/Preferred Qualifications (see Qualifications).