Mfg Tecnologies Sr Mgr

1001 Amgen Inc.; Holly Springs (NC); Híbrido; USD 137.000 - 186.000; Tempo integral

Benefícios oferecidos por esta vaga

Retirement plan

Medical, dental, vision coverage

Discretionary bonus

Stock-based incentives

Paid time off

Flexible work models

Resumo da vaga

Amgen Inc. is seeking a Manufacturing Technologies Senior Manager to oversee a defined set of MES objects (e.g., electronic batch records and equipment management).

You will collaborate with multi-functional teams, own global MES SOPs, and contribute to the application roadmap while ensuring data integrity and regulatory compliance. The role leads validation activities and documents for MES and some ERP areas, with a focus on cross-functional governance and strategic direction across

Qualificações

• Doctorate degree and 2 years of Manufacturing support experience.
• Master’s degree and 4 years of Manufacturing support experience.
• Bachelor’s degree and 6 years of Manufacturing support experience.
• Associate’s degree and 10 years of Manufacturing support experience.
• High School diploma / GED and 12 years of Manufacturing support experience.

Responsabilidades

• Collaborate, communicate, be accountable for leading forums with multi-functional areas and make the appropriate decisions for the best interest of Amgen.
• Strategize with Technology team on application roadmap and accommodating new offered functionality.
• Own system related controlled documents such as data integrity assessment report, operational SOPs, and training content.
• Lead and approve validation documents and records for MES and ERP.

Conhecimentos

Leadership experience

English proficiency

Cross-functional collaboration

Formação

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High School diploma

Ferramentas

Koerber PAS|X

MES technology knowledge

Descrição da vaga

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manufacturing Technologies Senior Manager

What you will do Let’s do this. Let’s change the world. In this vital role, you will manage a defined set of Manufacturing Execution Systems (MES) objects, such as GMBRs (electronic batch records) and equipment management objects (ESPs, state diagrams), that are utilized across all applicable manufacturing sites.

Specific responsibilities include but are not limited to:

• Collaborate, communicate be accountable for leading forums with multi-functional areas and make the appropriate decisions for the best interest of Amgen.
• May include ownership of global MES SOPs in addition of provide input and review of related global training materials.
• Strategize with Technology team on application roadmap and accommodating new offered functionality.
• Own system related controlled documents such as data integrity assessment report, operational SOPs, and training content.
• Lead and approve validation documents and records such as validation plan, OQ protocol, configuration specifications, requirements specs, validation summary (backup) report, test scripts, test sets, and test runs mostly for MES but also some for ERP.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manufacturing Technologies Sr. Manager professional we seek is a collaborative individual contributor leader with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of Manufacturing support experience
• Master’s degree and 4 years of Manufacturing support experience
• Bachelor’s degree and 6 years of Manufacturing support experience
• Associate’s degree and 10 years of Manufacturing support experience
• High School diploma / GED and 12 years of Manufacturing support experience

Preferred Qualifications

• Academic background in Life Science, and/or Engineering.
• Leadership experience managing contractors and indirect reports.
• Background in Drug Substance, Finish Drug Product (FDP) and/or Drug Product.
• MES technology knowledge with experience modifying batch records.
• Proficient communication skills in English.
• Experience with MBR design in Koerber’s PAS|X.
• MES system experience in biological manufacturing floor operations.
• Regulated environment work experience with cross-functional collaboration, working in teams.

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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 & vision coverage, life and disability insurance
• 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, including remote and hybrid work arrangements, where possible

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 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.

Equal Opportunity Employer

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 137,416.10USD -185,915.90 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen