Contract Development & Manufacturing Senior Manager

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped 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. 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Contract Development & Manufacturing Senior Manager

What you will do

Lets do this. Lets change the this vital role you will provide strategic and operational leadership within Amgen Contract Development and Manufacturing (ACDM) driving execution of external development and manufacturing activities for Synthetic Drug Substance (DS) programs supporting Antibody Drug Conjugate (ADC) and Small Molecule modalities across clinical and commercial stages.

This role is responsible for leading complex cross-functional programs with external development and manufacturing partners (CDMOs/CROs) to ensure reliable compliant and efficient supply execution. The successful candidate will demonstrate strong leadership capabilities technical breadth across synthetic modalities and the ability to influence internal and external stakeholders in a dynamic global environment. This position sits within External Supply in Operations and plays a critical role in enabling Amgens external sourcing and manufacturing strategy across the alignment with evolving business needs this role may also support additional hybrid or emerging modalities.

Key Responsibilities

• Lead external Synthetic DS programs for ADC and Small Molecule modalities across development clinical and commercial stages.

• Serve as the primary interface with CDMOs/CROs and internal cross-functional teams including Process Development Quality Supply Chain Analytical Regulatory and Strategic Sourcing.

• Drive sourcing activities including supplier selection onboarding scope of work development and proposal management.

• Oversee manufacturing operations technical transfers compliance and issue resolution with external partners.

• Ensure project delivery against quality compliance supply timeline and cost objectives.

• Lead risk management escalation resolution and operational decision-making across programs.

• Build strong internal and external partnerships to support program success and operational excellence.

• Influence and lead matrix teams in a fast-paced complex environment.

• Manage quality systems activities including deviations investigations change controls and CAPAs.

• Manage budgets purchase orders and financial forecasting for external manufacturing activities.

• Drive continuous improvement process optimization and operational excellence initiatives.

• Support supplier management and contract-related activities.

• Mentor and train ACDM staff and cross-functional teams and demonstrate strong leadership collaboration and accountability.

• Support additional hybrid or emerging modalities based on business needs.

• Travel up to 20% including domestic and international travel.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Manufacturing Operations Process Development or External Supply experience OR

• Masters degree and 4 years of Manufacturing Operations Process Development or External Supply experience OR

• Bachelors degree and 6 years of Manufacturing Operations Process Development or External Supply experience OR

• Associates degree and 10 years of Manufacturing Operations Process Development or External Supply experience OR

• High school diploma / GED and 12 years of Manufacturing Operations Process Development or External Supply experience

Preferred Qualifications:

• Advanced degree in Chemistry Chemical Engineering Pharmaceutical Sciences or related field preferred.

• 10 years of pharmaceutical or biotechnology experience in Synthetic DS development and manufacturing.

• Experience supporting Small Molecule and/or ADC modalities from development through commercial manufacturing.

• Proven leadership of external manufacturing programs with CDMOs/CROs in a cGMP environment.

• Strong knowledge of cGMPs quality systems regulatory/CMC requirements and pharmaceutical operations.

• Experience with sourcing strategies supplier management and commercial supply operations.

• Strong project management strategic thinking and problem-solving skills.

• Experience managing deviations investigations change controls and CAPAs with external partners.

• Demonstrated ability to lead and influence cross-functional matrixed teams.

• Strong communication collaboration negotiation and stakeholder management skills.

• Self-starter who thrives in fast-paced complex environments and drives continuous improvement.

• Demonstrated commitment to teamwork accountability innovation and patient focus.

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

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 and vision coverage life and disability insurance and flexible spending accounts

• 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

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