Senior Manager Process Engineering - Bulk Drug Substance - Downstream

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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Manager ProcessEngineeringDownstream

What you will do

Let’sdo this!Let’schange the world! In this vital role, you will oversee the engineering team, lead technical projects, and drive innovation in product design and manufacturing processes. You will solve complex engineering problems,optimizeprocesses, and ensure the company's engineering efforts align with strategicobjectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.

The Senior ManagerProcessEngineering will join the Facilities & Engineering (F&E) groupreporting to the Facilities & Engineering (F&E)Director,partnering closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domainexpertiseto support operations upon start-up, focusing onProcess engineering and plant equipmentas well as hiring and training the staff required to support startup and operations.

Key responsibilities include:

• Site design,construction, start-up, and operational readiness:
• Execute and guide thecommissioning and qualification ofprocess equipmentin alignment with GMP requirements, while working in partnership with global engineering during site installation. Ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery.
• Ensure systems are installed,operatingsafely,andcomplywithpertinentenvironmental health/safetypractice,rulesand regulations.
• Perform engineering assessmentsforplant equipmentoperations,implementing equipment modifications, and supporting engineering runsin support of new product/technology introductions asrequired.
• Site O perations:
• Provide system ownershipforprocess equipmenttypically used inbiologicsmanufacturing, includingDownstreamPurification(e.g.Chromatography and viral Filtration skids, UFDF), and CIP/SIPSkids.
• Lead a team ofProcessEngineeringprofessionals and serve as the main point of contact forProcessandequipment engineeringfunction.
• Establish clear expectations and prioritiestostaff. Encourage a culture of continuous improvement, partnership, and knowledge sharing.Providedevelopment opportunities, feedback, and actively listen to staff.
• Effectively collaborate with key customers and support groups (e.g.Manufacturing, Quality, Process Development, Maintenance, network partners).
• Work with original equipment manufacturers for breakdown and planned maintenance ofprocess equipment.
• Work with integrated service providers for day-to-day operational activities,breakdownand planned maintenance.
• Leadidentifyingand implementing engineering-based improvements or upgrades toprocessequipmentsystems.This may include developing business cases for improvements,identifyingdesign requirements, and translating these requirements intoprocessequipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
• Develop equipment maintenance programs, ensure the availability of spare parts, andcoordinatemaintenance activities to ensure systems are in proper working order.
• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for theprocessequipment.
• Providesystem guidance toidentifyperformance risks and implement risk reduction strategies.
• Provide technical support to troubleshoot,identifyand resolve process and system issues as needed.
• Provide strategic,tactical management,and leadershipto ensure24x7 day-to-dayreliability of plant operations.
• Participate in the budgeting process forprocess engineering, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.
• 10% domestic/international travel

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative individual weseekis a leader with these qualifications:

Basic Qualifications

• High school diploma / GED and 12 years of engineering experience OR
• Associate’s degree and 10 years of engineering experience OR
• Bachelor’s degree and 8 years of engineering experience OR
• Master’s degree and 6 years of engineering experience OR
• Doctorate degree and 2 years of engineering experience

And

• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

• Bachelor’s degree inChemicalorMechanical Engineeringor related technical field.
• 8+years'of relevant work experience with5+ years' experience in Biopharmaceuticaloperations/manufacturing environmentfocused onprocess andplantengineering function.
• Demonstratedpeoplemanagement/leadership experience.
• Direct knowledge of biopharmaceutical productionfacilitywith direct experience withDownstreamPurification(e.g.Chromatography and viral Filtration skids, UFDF), and CIP/SIPSkids.
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
• Experience working in a regulated environment (e.g.cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors,andfamiliarity with GMP quality systems/processes such as change control, non-conformances,corrective and preventative actions, and qualifications/validation
• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing
• Independent, ambitious, organized, able to multi-task in project environments, and skilled incommunication, facilitation, and teamwork
• Strong leadership, technical writing, and communication/presentation skills
• Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
• Work schedule flexibility asrequiredto support 24/7 operations, requiring occasional after-hours engineering coverage

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team!

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.