Senior Associate Manufacturing

Career Category

Manufacturing

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Manufacturing

What you will do

Let’s do this! Let’s change the world! The Manufacturing Senior Associate position will execute production unit operations and other activities supporting clinical and commercial operations for drug substance manufacturing in stainless steel and single-use equipment. The Manufacturing Senior Associate will monitor critical processes, complete routine validation protocols, and prepare documents such as Batch Records, SOPs and technical reports. They will perform basic troubleshooting and assist in the review and revision of documentation for assigned functions. The Senior Associate Manufacturing will participate on cross-functional teams, have the responsibility of owning NC/CAPAs, and will identify, recommend, and implement improvements related to routine functions. This role will interface between the GMP manufacturing teams in the plant and Quality, Engineering, and other partner organizations.

Job scope and responsibilities:

• Under minimal supervision, performs manufacturing processes according to Standard Operating Procedures.
• Set-up, clean, and sanitize equipment, and prepare media and buffers per procedures
• Lead, Perform, and monitor critical processes
• Align with cGMP's
• Analytical testing to support production, including pH, cell counting, protein concentration, etc.
• Revise controlled documents (e.g. MPs, SOP’s, and technical reports)
• Initiate and Close Minor Deviations
• Identify and recommend improvements to operations, and implement after approval
• Basic troubleshooting
• Recognize & accurately report problems
• Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
• Train new staff

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school/GED + 4 years biotech or pharmaceutical: manufacturing, process development or quality experience OR
• Associate’s + 2 years biotech or pharmaceutical: manufacturing, process development or quality experience OR
• Bachelor’s + 6 months biotech or pharmaceutical: manufacturing, process development or quality experience
• Master's

Preferred Qualifications:

• 5 years’ experience in a biomanufacturing environment
• Experience in Single Use and legacy Cell Culture and/or Purification Processing
• Experience and troubleshooting skills with laboratory and process equipment
• Experience with DeltaV, OSI PI, LIMS, TrackWise
• Understand, apply and evaluate basic chemistry, biology and physical principles
• Subject Matter Expert on at least one related unit operation
• Experience interacting with inspectors (internal and external)
• Experience working under current Good Manufacturing Practices (cGMP)
• Excellent written and oral communication skills
• Strong organizational and problem-solving skills
• Degree in life sciences, chemistry, or engineering
• Experience participating in and leading cross-functional teams
• Experience with execution of Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification
• Experience with aseptic operations in Grade 5 (Class 100) cleanrooms.
• Background in lean manufacturing methodologies and Operational Excellence
• Available for non-standard shifts including nights and weekends.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. Fro