Senior Associate Manufacturing - Continuous Improvement Lead

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Associate Manufacturing - Continuous Improvement Lead to support the start-up of a new manufacturing facility. This role involves overseeing operational readiness, managing manufacturing systems, and leading process improvement initiatives. The ideal candidate will possess strong project management skills and a background in Life Sciences or Engineering. Join this innovative team and make a significant impact on patient lives while advancing your career in a collaborative environment.

Qualifications

• 6 years of Manufacturing or Operations experience or 4 years with an Associate's degree.
• Strong technical knowledge of drug substance processing and bioprocessing.

Responsibilities

• Support operational readiness activities in various manufacturing areas.
• Manage and lead the Continuous Improvement program for manufacturing.

Skills

Project Management

Innovative Thinking

Technical Writing

Process Improvement

Lean Fundamentals

Education

High School Diploma / GED

Associate's Degree

Bachelor's Degree

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.

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 start-up 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, start-up, 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 cross-functional 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 cross-functional 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 well-being. 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.careers.amgen.com

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.