Contract Development and Manufacturing Manager

Career Category

Manufacturing

Job Description

Join Amgen's Mission to Serve Patients

At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.

Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.

If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Contract Development and Manufacturing Manager

What you will do

The Amgen Contract Development & Manufacturing (ACDM) organization is seeking a highly motivated Analytical Lead to drive external analytical strategy and execution across development, clinical, and commercial programs. This role serves as the primary ACDM analytical interface to CDMOs (Contract Development and Manufacturing Organizations) and CTLs (Contract Testing Laboratory), ensuring delivery against timelines, quality standards, and regulatory requirements.

This is a critical role within a highly matrixed, global organization supporting a dynamic portfolio of synthetic therapeutics, including peptides. ACDM, within External Supply in Operations, leads external sourcing and manufacturing strategies across the portfolio by leveraging a global network of partners to enable reliable supply and deliver high-quality medicines to patients.

The ideal candidate will thrive in a fast-paced, analytically driven environment and bring strong experience in analytical development and/or quality control, with the ability to translate technical strategy into execution across internal teams and external partners. Strong relationship management skills are essential. Experience supporting commercial analytical readiness, release, and lifecycle management is a plus.

Key responsibilities of this role include:

• Serve as the primary ACDM analytical lead for assigned programs, integrating analytical activities across development, validation, and commercial lifecycle

• Act as the single point of contact for external analytical partners (CDMOs/CTLs), ensuring alignment on scope, timelines, and deliverables

• Lead analytical strategy and execution, including method development, transfer, qualification, and validation, reference standard strategy and lifecycle management, release, and stability

• Drive end-to-end analytical planning and execution in close partnership with internal stakeholders (Process Development, Attribute Sciences, Quality, Supply Chain, Regulatory, etc.)

• Oversee external analytical operations, including proposal development, scope definition, work order execution, performance tracking, and issue resolution/escalation

• Ensure analytical deliverables meet quality, compliance, timeline, and cost expectations

• Proactively identify and mitigate analytical risks that may impact program execution, validation readiness, or product release

• Establish and maintain strong working relationships with internal and external stakeholders, driving effective communication and cross-functional alignment

• Contribute to continuous improvement efforts, including standardization of analytical approaches, governance, and external engagement models

• Operate with a high degree of independence while managing multiple priorities, programs, and business processes

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

What we expect of you

• Doctorate Degree

• Master’s degree in in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering or Life Sciences and 2 years of experience in pharmaceutical company or GMP environment OR

• Bachelor’s degree in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering or Life Sciences and 4 years of experience in pharmaceutical company or GMP environment OR

• Diploma in Synthetic Organic Chemistry, Analytical Chemistry, Chemical Engineering or Life Sciences, and 8 years of experience in pharmaceutical company or GMP environment

• Experience in analytical development, QC, or external analytical oversight within the pharmaceutical or biotechnology industry

• Experience working with CDMOs, CTLs, or external laboratory networks, including managing external partner relationships

• Strong project management and coordination skills, with the ability to manage multiple priorities and workstreams simultaneously

• Understanding of drug development lifecycle, from development through commercial supply

• Solid understanding of cGMP, regulatory/CMC requirements, and pharmaceutical quality systems  

• Experience with synthetic therapeutics (small molecules, peptides, or oligonucleotides) preferred

• Self-starter with a high-level of comfort with ambiguity and complexity and the ability to handle multiple workstreams while consistently delivering quality results 

• Demonstrated understanding of the technical aspects of manufacturing, testing, and controls; the regulations governing pharmaceutical operations, as well as financial systems and controls.

• Experience with change management, deviation investigations, and CAPA implementation

• Proven ability to operate effectively in cross-functional and matrixed teams, with strong written, verbal, and interpersonal communication skills

• Demonstrated strength in relationship management, including the ability to navigate, manage, and constructively resolve conflict

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.

What you can expect of us

As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.

Apply now and help transform the lives of patients while transforming your career.

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 as we 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.

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