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Contract Development & Manufacturing Senior Manager

BioSpace

Join Amgens Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll 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 In 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 Amgen's external sourcing and manufacturing strategy across the portfolio. In 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% (domestic and international). What We Expect Of You 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 From our competitive benefits to our collaborative culture, we support your professional and personal growth and well‑being. 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. 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. #J-18808-Ljbffr BioSpace

Vacancy posted 1 day ago
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