Contract Manufacturing Manager (Oligonucleotides, Peptides)

Career Category

Job Description

Join Amgen’s 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. 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 Manufacturing Manager (Oligonucleotides, Peptides)

What you will do

Let’s do this! Let’s change the world! In this vital role, you will be part of Amgen's Contract Development & Manufacturing (ACDM) team. This group was built to support Process Development’s sourcing strategy and drive the implementation of this strategy across the development portfolio. In this position, you will work with CRO/CMO’s to support development, clinical manufacture, and business management. You will also lead the implementation of sourcing initiatives and manage a variety of external projects engaging domestic, international, and emerging market suppliers.

The responsibilities of this role include:

• Project leadership for synthetic peptide and oligonucleotide external projects spanning development, clinical manufacture, and radiolabeling in close coordination with internal technical leads

• Work under minimal guidance to manage of multiple assignments and/or business processes

• Build and maintain positive relationships with all Process Development functions to increase overall efficiency and success of programs

• Supplier evaluation and outsourcing management including site selection activities

• Develop scopes of work in close partnership with technical leads

• Ensure projects and/or programs meet results, compliance, speed, quality, and cost

• Manage purchase orders, financial forecasting, and associated budget for externalization to adhere to financial targets and systems

• Establish and maintain external collaborations and monitor supplier performance to continuously improve efficiency and effectiveness of suppliers

• Identify project optimization opportunities (e.g., timeline, budget, technical completion)

• Present analyses and recommendations to Senior Management

• Occasional domestic and international travel to support project results

Preferred proximity to an Amgen site and the willingness to travel if needed.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a strategic problem solver with these qualifications.

Basic Qualifications:

• High school diploma/GED and 10 years of Scientific experience OR

• Associate's degree and 8 years of Scientific experience OR

• Bachelor’s degree and 4 years of Scientific experience OR

• Master’s degree and 2 years of Scientific experience OR

• Doctorate degree

Preferred Qualifications:

• Advanced degree in engineering or science

• Demonstrated understanding of drug development and commercialization for synthetic therapeutics, particularly synthetic peptides and oligonucleotides. This includes route scouting, raw material and starting material procurement, API/drug substance manufacture, process development, process engineering, and process characterization

• Experience working with domestic and international CMOs/CROs

• Solid understanding of cGMP, Regulatory/CMC, legal, quality requirements, and import/export policies

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

• Experienced team member of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiences

• An eye for business, high-level critical thinking, and strong problem-solving skills with the ability to structure, pragmatically scope, and solve problems

• Demonstrated quantitative skil