Contract Manufacturing Specialist

Amgen; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Contract Manufacturing Specialist to enhance efficiency and quality in production. This role involves providing technical support, managing project timelines, and ensuring compliance with quality standards. You will be a pivotal part of a collaborative team, driving continuous improvement and operational excellence. With a focus on serving patients, this opportunity offers a chance to grow within a diverse and inclusive environment while making a significant impact in the biotechnology field. If you're ready to take your career to the next level, this is the role for you.

Benefits

Learning opportunities

Diverse and inclusive community

Generous Total Rewards Plan

Qualifications

• Doctorate or Master's with 3 years in contract manufacturing management required.
• 5+ years in protein/API manufacturing preferred.

Responsibilities

• Provide technical support and solve complex production problems.
• Monitor site performance metrics and identify improvement opportunities.
• Manage project timelines and coordinate risk management activities.

Skills

Matrix management

cGMP knowledge

Negotiation skills

Operational Excellence

Financial/budgeting knowledge

Project management

Problem-solving

Technical writing

Leadership in collaborative environment

Initiative and action driving

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Job description

Career Category Manufacturing Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Contract Manufacturing Specialist

Live

What you will do

The Specialist in Manufacturing at Amgen provides technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.

Responsibilities:

1. Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
2. Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
3. Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.

Competencies

• Demonstrated matrix management and influencing skills.
• Manufacturing and cGMP knowledge / experience.
• Demonstrated negotiation skills.
• Operational Excellence proficiency and ability to drive continuous improvement.
• Financial/budgeting knowledge and business acumen.
• Proficient project management skills.
• Problem-solving and critical thinking.
• Understanding of contractual requirements.
• Technical writing and multi-level communication skills.
• Demonstrated ability to lead effectively in collaborative/team environment.
• Demonstrated ability to take initiative, drive action, and work under minimum supervision.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The management professional we seek is a collaborative cross-functional leader with these qualifications.

Basic Qualifications:

1. Doctorate degree
2. OR
3. Master’s degree and 3 years of contract manufacturing management experience
4. OR
5. Bachelor’s degree and 5 years of contract manufacturing management experience
6. OR
7. Associate’s degree and 10 years of contract manufacturing management experience
8. OR
9. High school diploma / GED and 12 years of contract manufacturing management experience

Preferred Qualifications:

• Bachelor’s in Business Administration, Engineering, or Science-related field
• Fluent in English and Japanese
• 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment
• 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
• 2+ years of project management experience leading multi-functional and/or multi-location team
• 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

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 a 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 an accommodation.