Manufacturing Associate

BioSpace; Thousand Oaks (CA); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Amgen Thousand Oaks Drug Substance plant is seeking a Manufacturing Associate to support development, clinical and commercial launch activities. Under general supervision, you will perform operations in the manufacturing area following SOPs and GMP requirements.

You will set up, clean, monitor processes, draft documents, and participate on cross-functional teams. Base qualifications include a Bachelor’s or an Associate with experience, or a high school diploma with relevant experience; shift

Formación

• Bachelor's degree or equivalent in a relevant field.
• Alternative: Associate degree with 6 months of manufacturing/operations experience.
• Or high school diploma/GED with 2 years of manufacturing/operations experience.

Responsabilidades

• Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures.
• Perform and monitor critical processes.
• Complete routine validation protocols.
• Follow GMPs.
• Draft and revise routine documents (e.g. MPs, SOPs, reports).
• Initiate Quality incidents.
• Identify and implement improvements after approval.
• May train staff or act as safety representative.
• Work shift rotations (12-hour days/nights) for 24/7 manufacturing.

Conocimientos

Hands-on operations

GMP knowledge

Troubleshooting

Quality incident handling

Cross-functional collaboration

Technical writing

Process monitoring

Educación

Bachelor's degree

Associate degree + 6 months experience

High school diploma/GED + 2 years experience

Herramientas

LIMS access

DeltaV / Automation

Descripción del empleo

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 do

Responsibilities

Lets do this. Lets change the world. In this dynamic role you will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and commercial launch activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs). Responsibilities include:

• Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures
• Perform and monitor critical processes
• Complete routine validation protocols
• Follow GMP's
• Regularly draft and revise routine documents (e.g. MPs, SOPs, and technical reports)
• Initiate Quality incidents
• Identify and recommend improvements related to routine functions and implement after approval
• Basic troubleshooting
• Recognize & accurately report problems
• Direct operators on critical processes
• Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
• May train staff to perform hands-on tasks
• May act as safety representative
• May participate on cross-functional teams and represent the Purification group
• Must be flexible to work any shift assignment in support of 24/7 manufacturing operations. 12 hour shift (Days or Nights) rotation.

What we expect of you

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

Bachelors degree OR Associates degree and 6 months of manufacturing or operations experience OR High school diploma / GED and 2 years of manufacturing or operations experience

Preferred Qualifications

Available for non-standard shifts including graveyard shift and weekends

• Knowledge of large scale Purification operations, chromatography, TFF, aseptic processing
• CFR and Regulatory knowledge
• Mechanical ability/expertise
• Knowledge of WIP lab equipment and computers, with LIMS access
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Ability to demonstrate technical writing capability with Trackwise access
• Able to demonstrate project management skills and presentation skills
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on Purification equipment
• Experience with Delta V / automation

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. 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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 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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.