Associate Manufacturing
Amgen
2024-11-15 02:53:26
Newbury Park, California, United States
Job type: fulltime
Job industry: Manufacturing Operations
Job description
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Associate Manufacturing
What you will doLets do this! Lets change the world! In this dynamic role you will collaborate with multiple functions within the Thousand Oaks site on a routine basis in a dynamic environment (Quality Assurance, Quality Control, Engineering, Facilities, Maintenance, Process Development, Process Engineering, etc.) while developing a deep understanding of the manufacturing operations and planning activities within the facility.
Responsibilities:- Performing drug product analytical testing for compendia based assays
- Performing drug product manual visual inspection activities, respectively
- Performing initial review of manufacturing batch records
- Maintaining a safe and compliant culture by identifying preventative measures
- Creating and/or revising standard operating procedures
- Leading continuous improvement initiatives, which may be cross-functional in nature
- Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
- Developing finite schedule for tasks including, but not limited to unit operations
- Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
- Elevating critical and impactful events to management
- Applying appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
- Supporting the introduction of new products and technologies into the facility
- Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)
We are all different, yet we all use our unique contributions to serve patients. The Manufacturing professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
- High school/GED + 2 years GMP/GDP experience OR
- Associates + 6 months of GMP/GDP experience OR
- Bachelors
Preferred Qualifications:
- B.S. in a life science or related field
- 2 years of work experience in a GMP environment
- Ability to perform computer operations, such as ability to navigate in MS Office and Excel
- Ability to operate specialized equipment and computers as appropriate to the individual area
- Ability to adhere to regulatory requirements, written procedures and safety guidelines
- Ability to evaluate documentation/data according to company and regulatory guidelines
- Ability to interact with inspectors (internal and external)
- Technical writing capabilities
- Ability to organize work, handle multiple priorities and meet deadlines
- Demonstrated written and oral communication skills
- Presentation capabilities
- Detail oriented as well as flexible and adaptable to changing priorities and requirements.
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. From our competitive benefits to our collaborative culture, well 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, including remote and hybrid work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
In 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 deadlineAmgen 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.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.