Contract Development and Manufacturing Manager

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. 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 and Manufacturing Manager

What you will do

Lets do this. Lets change the world. In this vital role you will show a strong desire to work in a fast-paced environment leading clinical and commercial programs and quickly adapt strategies to support the dynamic portfolio. The ability to build and maintain relationships, internally and externally, is critical. Understanding commercial supply to develop a robust supply chain is an advantage. Key responsibilities of this role include:

• Key point of contact / interface with CDMOs / CROs, executing the tactical management of external synthetics and/or process chemistry-focused projects, spanning development, clinical manufacture, and commercial manufacture in close collaboration with Amgens technical and functional leads (Drug Substance, Analytical, Quality, Supply Chain, and others)
• 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
• Supplier evaluation and outsourcing management including site selection activities
• Overseeing quality aspects of the site engagement and enables timely resolution of issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, and change management as needed
• Build and maintain positive relationships with all Process Development and Operations functions to increase overall efficiency and success of programs
• Ensure projects and/or programs meet results, compliance, speed, quality, and cost
• Budget management, including purchase orders, financial forecasting, and associated finance cycles for externalization, adhering to financial targets and systems
• Identifies optimization opportunities and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability
• Establish and maintain external collaborations and monitor supplier performance to continuously improve efficiency and effectiveness of suppliers
• Present analyses and recommendations to Senior Management
• Occasional domestic and international travel to support project results
• Performing other related duties and tasks as necessary or as assigned, potentially in other areas of external supply
• Ability to work under minimal guidance to manage multiple assignments and/or business processes

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Manufacturing experience; Or
• Associates degree and 8 years of Manufacturing experience; Or
• Bachelors degree and 4 years of Manufacturing experience; Or
• Masters degree and 2 years of Manufacturing experience; Or
• Doctorate degree

Preferred Qualifications:

• Advanced degree in chemistry or chemical engineering
• 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; engineering; plant operations; the regulations governing pharmaceutical operations, as well as financial systems and controls.
• Understanding of cGMP, Operations and Regulatory/CMC policies and requirements
• Knowledge of the contract manufacturing organization (CMO) landscape
• Experience with interfacing and managing CMO and CDMO relationships
• Demonstrated quantitative skills including experience in business process development, cost of goods analysis, continuous improvement, operational excellence, and performance management
• Experience with change management, deviation investigations and implementation of corrective/preventive actions
• Experienced team member of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiences
• Strong Project management and coordination skills/experiences
• Strong interpersonal relationship and communication skills and ability to understand and contribute to resolution of conflict in a constructive manner
• Possesses strong business acumen, exceptional critical thinking, and advanced problem-solving skills. Demonstrates the ability to structure, pragmatically scope, and effectively resolve complex issues.

What you can expect from 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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. 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 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.

Location: Cambridge, MA, US

Posted Date: 11/30/2024