Contract development and manufacturing manager

Amgen; United States; Remote; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking a Contract Development and Manufacturing Manager to lead external partnerships in the Asia Pacific region. This pivotal role involves overseeing clinical and commercial supply chains while ensuring compliance with Good Manufacturing Practices. The ideal candidate will have a strong background in synthetic organic chemistry and experience managing relationships with contract development and manufacturing organizations. Join a dynamic team that values innovation and collaboration, and contribute to delivering vital medicines to patients worldwide.

Benefits

Generous Total Rewards Plan

Opportunities for professional growth

Inclusive community environment

Work/life balance benefits

Qualifications

• Strong knowledge of synthetic drug development and manufacturing.
• Experience managing CRO and CDMO relationships.
• Understanding of tech transfer and commercialization processes.

Responsibilities

• Oversee external programs and ensure compliance with quality and timelines.
• Manage financial aspects including budgeting and forecasting.
• Coordinate shipment requests and oversee quality engagements.

Skills

Synthetic Organic Chemistry

Chemical Engineering

Project Management

Interpersonal Communication

cGMP Compliance

Change Management

Cross-functional Team Leadership

Education

Doctorate in Synthetic Organic Chemistry

Master's in Synthetic Organic Chemistry

Bachelor's in Synthetic Organic Chemistry

Diploma in Synthetic Organic Chemistry

Job description

Career Category Manufacturing Job Description

Contract Development and Manufacturing Manager

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Contract Development and Manufacturing Manager in Amgen Singapore Manufacturing.

Live

What you will do

The Amgen Contract Development and Manufacturing (ACDM) Organization is seeking a highly qualified candidate to handle Amgen’s external network of development and manufacturing partners in the Asia Pacific region to ensure uninterrupted clinical and commercial supply for Amgen’s portfolio. The position will be in the Synthetic Small Molecule Drug Substance business unit of ACDM and will focus on the late-phase clinical and commercial portfolio. This is a key role in a strong cross-functional, global organization and will support technology / process development, supplier onboarding and relationship management, oversight of manufacturing activities, and implementation of sourcing strategies (e.g., scope of work, proposal request execution, participation in site selections)

The Amgen Contract Development and Manufacturing team is part of the External Supply Organization within Amgen Manufacturing. This team develops and implements the external sourcing strategy for Amgen’s portfolio from early phase through commercial delivery. Amgen Contract Development and Manufacturing leverages a network of global assets to create exceptional value for Amgen and deliver vital medicines for our patients. This role will support engagement and oversight of Contract Development and Manufacturing Organizations (CDMO's) through executing activities according to Good Manufacturing Practices (cGMP) principles and the ACDM business practices.

Main Responsibilities:

The successful candidate will demonstrate a strong desire to work in an expanding region for Amgen, leading clinical and commercial programs. Ability to build and maintain relationships, internally and externally is critical. Understanding of commercial supply to develop a robust supply chain is an advantage. Key responsibilities of this role include:

• Day-to-day oversight for external programs and deliverables
• Overseeing ongoing activities at selected sites along with any subcontracted sites to ensure project deliverables, including compliance, timelines, product quality, and cost
• Working closely with the ACDM team and internal stakeholders (Quality, Supply Chain, Process Development) to support sourcing activities, including generating and managing scope of work (SoW) and quotation request documents
• Financial management of budget (OPEX, CAPEX and COGM), financial forecasting and management of purchase orders and invoices
• Coordinating requests for shipment of materials/samples between sites
• Overseeing quality aspects of the site engagement, such as deviations investigations and change managements as needed
• Performing other related duties and tasks as necessary or as assigned, potentially in other areas of external supply

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Win What we expect of you Basic Qualifications

• Doctorate degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences OR
• Master’s degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences and 2 years of directly related pharmaceutical industry experience OR
• Bachelor’s degree in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences and 4 years of directly related pharmaceutical industry experience OR
• Diploma in Synthetic Organic Chemistry, Chemical Engineering or Life Sciences and 8 years of directly related pharmaceutical industry experience

• Knowledge of synthetic drug development and manufacturing
• Understanding of cGMP, Operations and Regulatory/CMC policies and requirements
• Experience with interfacing and managing CRO and CDMO relationships
• International experience working with companies in the JAPAC regions, specifically India and China
• Experience with change management, deviation investigations and implementation of corrective/preventive actions
• Understanding of tech transfer, drug development and commercialization of synthetic therapeutics
• Experience working in cross-functional settings
• Experience as a team member or leader of cross-functional or matrix team
• Strong Project management and coordination skills/experiences
• Strong interpersonal relationship and communication skills both written and verbal

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company. Thrive

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.

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