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Contract Development & Mfg Sr Mgr
Contract Development & Mfg Sr MgrAmgen • Boulder, CO, US
Contract Development & Mfg Sr Mgr

Contract Development & Mfg Sr Mgr

Amgen • Boulder, CO, US
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  • [job_card.full_time]
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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 missionto serve patients living with serious illnessesdrives 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.

Basic Qualifications :

  • 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
  • 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 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
  • What you can expect of 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, we'll 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
  • 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.

    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.

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