Product Manager

Amgen Manager-New Product Introduction (NPI) and Manufacturing Execution System (MES)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 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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.Responsibilities:Directly manage a team of Downstream NPI Specialists and MES Sr. Associates responsible for introduction of new products and/or advanced technologies into the plant, as well as Electronic Batch Record (EBR) development and management. Includes hiring, training, oversight, performance evaluations, and development.Proactively assess team capabilities to meet the evolving drug substance clinical/commercial supply needs (ex. resources, platform technical understanding, cross-functional alignment).Lead downstream area team meetings and drive alignment in business processes across the team.Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality, MES network, as well as Manufacturing for the introduction of new products, new/revised electronic batch records, and/or advanced technologies into the plant.Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.Collaborate with Regulatory and Quality partners to ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings.Drive a culture of inspection readiness across the team by ensuring NPI and MES playbooks are kept up to date and supporting staff with audit or regulatory response strategy.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.Doctorate degree ORMaster's degree and 3 years of biotechnology operations experience ORBachelor's degree and 5 years of biotechnology operations experience ORAssociate's degree and 10 years of biotechnology operations experienceANDIn addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced abovePreferred Qualifications:Degree in Chemical Engineering, Industrial Engineering, Biology or BiochemistryExperience leading/managing a team of direct reportsExperience with PAS X, Werum softwareExperience in GMP operations, including New Product Introduction (NPI)Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessingAbility to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing formsAbility to coach, mentor and/or cross train colleagues within core technical areasBackground in lean manufacturing methodologies and operational excellenceExperience in cross functional Project ManagementWhat you can expect from 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.Apply now and make a lasting impact with the Amgen team.