Specialist Manufacturing New Product Introduction (NPI)

Holly Springs, MS - USA

Monthly Salary: $ 139433 - 139433

Posted on: 20 hours ago

Vacancies: 1 Vacancy

Job Summary

Career Category

Manufacturing

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel likeyourepart of something biggeritsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980wevehelped 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 teamyoullhelp 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 thatliewithin themyoullthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Specialist ManufacturingNew Product Introduction (NPI)

Live

What you will do

Letsdo this.Letschange the world.In this vital role you will communicate and interface between the GMP manufacturing teams in theAmgen North Carolina (ANC) Biologics Drug Substance ManufacturingplantandProcessDevelopment scientific groups.As part of ANCs Manufacturing Supportteam this positionis responsibleforensuring new products are successfully introduced intoANCsbiologicsmanufacturingfacility.It is ahighly visible role across the site with the core responsibility ofhosting cross-functional meetings todrive totimelines to support the tech transfer of the program into the facility.This role will also offer the opportunity to proposeparticipate and lead team improvement initiatives to drive improved productivity and scheduling accuracy.

New Product Introduction lead coordinating withManufacturing Process DevelopmentSupply Chain Planning Facilities and Engineeringas well asQuality to introduce new Drug Substance products and/or advanced technologies into the plantusingproject management tools(i.e.Smartsheet).

Technical expert who leads orparticipatesin projects ensuring that production documents areaccurateand up to date.

Support Manufacturing in troubleshooting problemsolvingand RCAs. Support CAPA development to prevent error recurrence.

Owns New Product Introduction Change Controlsand collaborateswithstakeholders to drive on-time completion.Respondsto regulatory questions and/or audit findings.

Champions Lean Transformation and OEinitiativesfacilitatesthe drive towards continuous improvement in the plant and tracks progress on a plant level.

Win

What we expect of you

We are all different yet we all use our unique contributions to serve patients. Themanufacturingprofessional weseekhas a biologics DSmanufacturing background withstrongcross-functional project managementandcommunicationskillsas well asthebelowqualifications.

Basic Qualifications:

High school diploma / GED & 10 years of biotechnology operations experience OR
Associates degree & 8 years of biotechnology operations experience OR
Bachelors degree and 4 years of biotechnology operations experience OR
Masters degree in chemistry biology or engineering & 2 years of biotechnology operations experience OR
Doctorate degree

Preferred Qualifications:

Degree in Chemical Engineering Industrial Engineering Biology or Biochemistry

Excellentcross-functionalproject management meeting facilitation andtechnical writing skills

Experience in GMPmanufacturingoperations

Strong technical knowledge of drug substance processing (chromatography filtration buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing (cell culture harvest)

Ability to organizeanalyzeand interpret technical data through trend analysis forecasting modeling etc.

Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writingforms

Ability to coachmentorand/or cross train colleagues within core technical areas

Background in lean manufacturing methodologies and operational excellence

Thrive

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.

The annual base salary range for this opportunity in the U.S. is provided below.

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:

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 programor forfield sales representatives a sales-based incentive plan.

Stock-based long-term incentives.

Award-winning time-off plans and bi-annual company-wide shutdowns.

Flexible work models including remote work arrangements where possible.

Applynowfor a career that defies imagination

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

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 toparticipatein 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.

#AmgenNorthCarolina

Salary Range

114990.00 USD - 139433.00 USD

Required Experience:

Career CategoryManufacturingJob DescriptionJoin Amgens Mission of Serving PatientsAt Amgen if you feel likeyourepart of something biggeritsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980wevehelped pioneer the world of biotech in our ...