Career CategoryManufacturing
Job DescriptionSenior Associate ManufacturingWhat you will doLet'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.
Job Scope and Responsibilities:
- Under minimal supervision, 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
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Basic Qualifications: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)
Preferred Qualifications:- 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
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
Salary Range86,048.05USD -116,417.95 USD
