Contract Development

2 weeks ago


Boulder, United States Amgen Full time

Join Amgen's Mission of Serving PatientsAt 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 MgrWhat you will doLet'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 leadsIdentify and establish peptide and oligonucleotide capabilities as neededWork under minimal guidance to manage of multiple assignments and/or business processesBuild and maintain positive relationships with all Process Development functions to increase overall efficiency and success of programsSupplier evaluation and outsourcing management including site selection activitiesDevelop scopes of work in close partnership with technical leadsEnsure projects and/or programs meet results, compliance, speed, quality, and costManage purchase orders, financial forecasting, and associated budget for externalization to adhere to financial targets and systemsEstablish and maintain external collaborations and monitor supplier performance to continuously improve efficiency and effectiveness of suppliersIdentify project optimization opportunities (e.g., timeline, budget, technical completion)Present analyses and recommendations to Senior ManagementPeriodic domestic and international travel to support project resultsWhat we expect of youWe 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 experienceOrMaster's degree and 4 years of Scientific or Business Management experienceOrBachelor's degree and 6 years of Scientific or Business Management experienceOrAssociate's degree and 10 years of Scientific or Business Management experienceOrHigh school diploma / GED and 12 years of Scientific or Business Management experiencePreferred Qualifications:Advanced degree in engineering or scienceDemonstrated 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 validationExperience working with domestic and international CMOs/CROsSolid understanding of cGMP, Regulatory/CMC, legal, quality requirements, and import/export policiesSelf-starter with a high-level of comfort with ambiguity and complexity and the ability to multitask while consistently delivering quality resultsExperienced team member of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiencesAn eye for business, high-level strategic thinking, and strong problem-solving skills with the ability to structure, pragmatically scope, and solve problemsDemonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance managementPreferred proximity to CMO and the willingness to travel if neededWhat you can expect of usAs 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible 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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