Senior Manager, Contract Development & Manufacturing

Amgen

Senior Manager at Amgen driving contract development and manufacturing activities for Synthetic Drug Substances. Collaborating with internal and external teams to ensure compliance and efficiency.

Posted 6/26/2026full-timeThousand Oaks • California, Massachusetts • 🇺🇸 United StatesSenior💰 $138,394 - $187,239 per yearWebsite

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Hard Skills

ManufacturingOperationsProcess DevelopmentExternal SupplySynthetic Drug SubstanceAntibody Drug ConjugateSmall MoleculecGMPQuality SystemsRegulatory/CMC Requirements

Soft Skills

LeadershipCollaborationAccountabilityStrategic ThinkingProblem-SolvingCommunicationNegotiationStakeholder ManagementTeamworkContinuous Improvement

Tools & Technologies

CDMOsCROsQuality Management SystemsSupplier Management SystemsFinancial Forecasting ToolsProject Management SoftwareChange Control SystemsCAPA Management SystemsManufacturing Operations SoftwareSourcing Management Tools

Industry Keywords

PharmaceuticalBiotechnologySynthetic DS DevelopmentCommercial ManufacturingSupplier SelectionOnboardingScope of Work DevelopmentProposal ManagementRisk ManagementOperational Excellence

About the role

Key responsibilities & impact

Provide strategic and operational leadership within Amgen Contract Development and Manufacturing (ACDM)
Drive 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.
Lead complex, cross-functional programs with external development and manufacturing partners (CDMOs/CROs) to ensure reliable, compliant, and efficient supply execution.
Influence internal and external stakeholders in a dynamic global environment.
Serve as the primary interface with CDMOs/CROs and internal cross-functional teams.
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.
Manage quality systems activities including deviations, investigations, change controls, and CAPAs.
Manage budgets, purchase orders, and financial forecasting for external manufacturing activities.
Mentor and train ACDM staff and cross-functional teams and demonstrate strong leadership, collaboration, and accountability.

Requirements

What you’ll need

Doctorate degree and 2 years of Manufacturing, Operations, Process Development, or External Supply experience OR Master’s degree and 4 years of Manufacturing, Operations, Process Development, or External Supply experience OR Bachelor’s degree and 6 years of Manufacturing, Operations, Process Development, or External Supply experience OR Associate’s 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
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.

Benefits

Comp & perks

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
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.