Contract Development & Mfg Sr Mgr

Amgen•Denver, CO

22d

About The Position

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 Development & Mfg Sr Mgr What you will do Let’s do this. Let’s change the world. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this important role. Site Lead and project leadership for synthetic peptide and oligonucleotide external projects spanning development, clinical and commercial manufacture in close coordination with internal technical leads Identify and establish peptide and oligonucleotide capabilities as needed 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 Periodic domestic and international travel to support project results What we expect of you We are all different, yet we all use our unique contributions to serve patients. Ideally, the candidate resides in the geography.

Requirements

Doctorate degree and 2 years of Scientific or Business Management experience Or Master’s degree and 4 years of Scientific or Business Management experience Or Bachelor’s degree and 6 years of Scientific or Business Management experience Or Associate’s degree and 10 years of Scientific or Business Management experience Or High school diploma / GED and 12 years of Scientific or Business Management experience

Nice To Haves

Advanced degree in engineering or science
Demonstrated understanding of drug development and commercialization for synthetic therapeutics, particularly synthetic peptides and oligonucleotides. This includes preclinical development, raw material and starting material procurement, clinical and commercial API/drug substance manufacture, process development, process engineering, process characterization and process validation
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 multitask 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 strategic thinking, and strong problem-solving skills with the ability to structure, pragmatically scope, and solve problems
Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management
Preferred proximity to CMO and the willingness to travel if needed

Responsibilities

Site Lead and project leadership for synthetic peptide and oligonucleotide external projects spanning development, clinical and commercial manufacture in close coordination with internal technical leads
Identify and establish peptide and oligonucleotide capabilities as needed
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
Periodic domestic and international travel to support project results

Benefits

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.

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