Specialist Manufacturing

Career Category

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 awardwinning 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.

Specialist Manufacturing Associate

What you will do

Lets do this. Lets change the world. In this vital role you will be part of the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction new technology and equipment introduction continual improvement projects supporting the multiproduct facility operation program CAPA ownership deviation trending and optimization/implementation of single use technologies. The position is within the drug substance supply organization in ATO Building 23 which is a dynamic environment and an important launch point for Amgens pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production. We are seeking an experienced Specialist for the Manufacturing Team to execute a variety of production and process related changes to operations in a largescale manufacturing plant. This Specialist will own corrective and preventative projects that are implemented into the manufacturing plant. A significant amount of time will be spent working on a collaborative team to identify appropriate corrective/preventive actions and implementing them. Some handson work on the plant floor executing runs and experiments working with largescale equipment analyzing and summarizing data findings will be required. Additional activities will include defining and documenting operation practices ensuring documentation accurately reflects operations performed implementing area improvements commissioning equipment design of experiments effectively communicating findings and participating in operations meetings.

Responsibilities:

• Support manufacturing by providing subjectmatter expertise for drug substance upstream and downstream processes as process owner (PPO) or Singleuse SME
• Lead crossfunction and complex projects using project management skills.
• Resolve quick issues and lead troubleshooting including of function tests to troubleshoot and optimize process.
• Write protocols and reports in support of validation function testing equipment commissioning and qualification and change management.
• Own Quality Records such as CCMS CAPA and CAPAEV.
• Apply technical process scientific operational and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
• Demonstrate strategic problemsolving skills and champion continual improvement.
• Present to inspectors on areas of expertise.
• Mentor and train junior staff.
• Ability to be onsite (flexible worker)
• Available to work various shifts (day swing graves weekends holidays 5x8hrs 4x10hrs) as instructed by the production schedule to execute functiontesting and project tasks with minimal disruption to operations.
• Must be able to work in a clean room environment wearing steel toe shoes full clean room gowning hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.

As Process owner:

• Lead operational readiness of new technologies equipment or processes by applying technical process scientific operational and compliance knowledge with project management skills
• Provide assessment and advice on process impact for changes
• Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs Forms). Draft and develop user requirements for new technologies. .

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The collaborative professional we seek is a teamplayer partner with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 2 years of manufacturing and or operations experience

Or

Bachelors degree and 4 years of manufacturing and or operations experience

Or

Associates degree and 8 years of manufacturing and or operations experience

Or

High school diploma / GED and 10 years of manufacturing and or operations experience

Preferred Qualifications:

• Degree in Engineering or Life Sciences
• 3 years or more experience in Drug substance GMP technical support roles GMP manufacturing Engineering Process Development or equivalent.
• Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
• Ability to navigate through ambiguity and identify and deliver on key milestones.
• Ability to advise and influence using experience and data.
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach mentor and/or cross train colleagues within core technical area.
• Team player Ability to support process owner team by reprioritizing or readjusting projects tasks or responsibilities.
• Ability to drive results through leadership of crossfunctional teams
• Experience leading and managing projects
• Understanding of singleuse technologies
• Data analysis and/or data visualization skills
• Excellent writing skills. Presentation experience presentation to leadership or auditors.
• Determines work tasks and timelines selfsufficiently ability to navigate through ambiguity and prioritize effectively
• Proficiency in Smartsheet and excel Trackwise Visio pi SAP Spotfire

What you can expect from us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. 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 salesbased incentive plan
• Stockbased longterm incentives
• Awardwinning timeoff plans
• Flexible work models including remote and hybrid work arrangements where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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. 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.

Salary Range