Sr. Associate Manufacturing - AML 7
Amgen
**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.
Sr. Associate Manufacturing - AML7
**What you will do**
Let’s do this. Let’s change the world. In this vital role you will seek a variety of challenges and responsibilities within the Bacterial Fermentation and Purification with the Drug Substance Organization. Support manufacturing operations in a Non-Standard shift structure organization including weekends, holidays and extended hours. Multiple positions available.
**Specific responsibilities include but are not limited to:**
+ Work with manufacturing and quality systems such as: risk management, deviations, process monitoring & validation, process improvements procedures, training, and new product introductions, in support to manufacturing operations.
+ Prepare, operate and troubleshoot manufacturing equipment
+ Provide support with the set-up of Fermentors, Cell Culture Process, filtration skids, buffer/media preparation
+ Perform analytical testing, pH, Cond, Protein concentration, Endotoxins and others
+ Involved in monitoring sampling, and testing, use pumps, disposal bags and aseptic connectors
+ Document procedures and results
+ Documentation revision and Standard operational procedures revision
+ Participate in the manufacturing review process including the Electronic Batch Record (EBR) revision and closure process
+ Initiate minor deviation, ARA, including managing Trackwise record
+ Active participation in the task delegation process and shift changes meeting
+ Support as Subject Matter Expert for critical processes and provide training to the team
+ Participate in the New Product Introduction (NPI) process providing manufacturing support
+ May lead initiatives related to training strategies and operational excellence to support manufacturing areas
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Sr. Associate Manufacturing we seek is an individual contributor professional with the following qualifications.
**Basic Qualifications:**
High school/GED and 4 years of manufacturing support experience
OR
Associate degree and 2 years of manufacturing support experience
OR
Bachelor’s Degree and 6 months of manufacturing support experience
OR
Master's Degree
**Preferred Qualifications:**
+ Educational background in Life/Natural Science and/or Engineering
+ Work experience in a manufacturing GMP regulated environment.
+ Knowledge in manufacturing process as CIP, SIP, inoculation process, process monitoring and equipment preparation.
+ Equipment troubleshooting skills (sample analysis issues)
+ Knowledge and Experience with Technical Writing including good documentation skills.
+ Knowledge and experience with bio-processing unit operations
+ Knowledge with basic computer operations, such as ability to use MS Office tools, Outlook, Power Point, Word and Excel
+ Good presentation, project management, and organization skills to perform assignments with a high degree of attention to detail.
+ Written and verbal communication skills in both English and Spanish.
+ Experience working with cross-functional teams
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
+ 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 and an annual site shutdown
+ Flexible work models, including remote work arrangements, where possible
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
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.
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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
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