Senior Associate Manufacturing - Continuous Improvement Lead
Senior Associate Manufacturing - Continuous Improvement Lead
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$ 106188 - 106188
1 Vacancy
Job Description
Career Category
ManufacturingJob 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.
Senior Associate Manufacturing Continuous Improvement Lead
What you will do
Lets do this. Lets change the world. In this vital role you will have the outstanding opportunity to support the startup of the Amgen North Carolina (ANC) manufacturing facility.
During start up the Manufacturing Senior Associate Continuous Improvement (CI) Leads will have ownership and oversight of operational readiness activities in manufacturing areas such as: Dispensing Buffer/Media Preparation Upstream Cell Culture Harvest Downstream Purification Analytical Testing or Column Packing. CI leads will support Standard Operating Procedure (SOP) creation review and approval; specification and purchasing of required equipment and supplies design of job aids and work instructions advancement of digital tools to support manufacturing operations and training of staff. When the plant transitions to operations in 2025 this position will manage and lead the CI program for MFG.
- Provide technical support and subject matter expertise for manufacturing area.
- Oversee support and ongoing development of all the manufacturing systems including SOP TRNQ MES QMS records among others.
- Train staff (associates operators technical/QA/support) on assigned manufacturing systems.
- Support troubleshooting needs during commissioning/qualification startup engineering run and process performance qualification of the ANC manufacturing facility
- Facilitate process area and equipment quality risk assessments as needed to identify risks failure modes and mitigating actions.
- When the plant is in production manage the CI program; this includes conducting time studies to identify process inefficiencies leading improvement projects in designated MFG area (i.e. upstream downstream solution prep) implementing proper change management and tracking sustainment of implemented changes.
- Lead crossfunctional CAPAs and EVs as required.
- Serve as a CI and Human and Organizational Performance champion. Provide training to others on CI and lean principles.
- Lead learning team meetings and kaizen events.
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The professional we seek will possess strong project management and innovative thinking as well as these qualifications.
Basic Qualifications:
- High school diploma / GED and 6 years of Manufacturing or Operations experience OR
- Associates degree and 4 years of Manufacturing or Operations experience OR
- Bachelors degree and 6 months of Manufacturing or Operations experience
Preferred Qualifications:
- Educational background in Life Sciences Chemistry Biochemistry Industrial Biotechnology and/or Engineering
- Strong technical knowledge of drug substance processing (cell culture harvest chromatography filtration buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
- Proficient technical writing and presentation skills so as to communicate complex information effectively with technical and senior management staff
- Ability to lead small and large crossfunctional meetings efficiently.
- Knowledge of process improvement or lean fundamentals.
- Collaborate with staff at all levels in the organization including technical and management staff within manufacturing process development engineering supply chain and quality
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 wellbeing. From our competitive benefits to our collaborative culture well support your journey every step of the way.
In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
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.
.Salary Range
88378.00 USD 106188.00 USDRequired Experience:
Senior IC
Employment Type
Full-Time
