Senior Associate Manufacturing

Amgen • Thousand Oaks, CA

2d • $86,048 - $116,418

About The Position

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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 is part of the Amgen, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection team. This Senior Associate position will be focused on: Characterization, data, and equipment management Process improvement projects/assignments within operations Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support Support new product introduction activities Support production Maintain open communication between operations teams This Senior Associate position will be focused on manual visual inspection operations.

Requirements

• Master’s degree OR Bachelor’s degree and 6 months of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR Associate’s degree and 2 years of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR High School Diploma/GED and 4 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)

Nice To Haves

• Prior experience with lab equipment, computers, and intermediate mathematical skills
• Significant experience with manual visual inspection in a GMP regulated environment.
• Significant experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
• Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
• Demonstrated technical writing skills
• Strong knowledge of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
• Demonstrated ability to work in a team

Responsibilities

• Performs manufacturing unit operations according to Standard Operating Procedures
• May schedule operations for multiple functional areas
• Understand process parameters and can identify process anomalies
• Perform data analysis of critical process parameters
• Operate complex critical processing equipment
• Assist, plan and implement continuous improvement solutions related to routine functions
• Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks
• Primary resource related to processing operations on the mfg. floor
• Identify and propose solutions to complex problems
• Responsible for resolving problems during operations
• Perform initial review of manufacturing procedures/batch records
• Review, revise, and audit documents
• Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
• Provide process theory expertise and hands-on training to others
• Own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
• Applies research, information gathering, and interpretation skills to problems of diverse scope
• Utilizes project management skills to set project timelines and priorities based project objectives and ongoing assignments
• Recognizes and escalates problems
• Able to establish working relationships with others outside area of expertise
• Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)
• Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles as appropriate for the position
• Organizational skills and an ability to perform assignments with a high degree of attention to detail
• Written and oral communication skills.
• Technical writing capability
• GMP knowledge with ability to interpret and apply applicable regulations

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed