Sr Associate Process Development

Amgen
Cambridge, MA
**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. **Sr Associate Process Development** **What you will do** Let's do this! Let's change the world! Amgen is a global leader in biotechnology, pioneering innovative medicines and cutting-edge manufacturing for over four decades. Our mission: to serve patients through science and technology. We're looking for a Senior Associate, Process Development at our Cambridge Process Development Pilot Plant ("Scale-Up Lab")-a hands-on innovator ready to drive Amgen's mission forward. In this role, you'll design, develop, and optimize manufacturing processes up to the 2000L scale, lead pilot-scale experiments, and implement process improvements that enhance product quality and efficiency. You'll also help guide junior staff, ensure production excellence, and champion new technologies and automation initiatives. Working in an integrated cell culture and purification organization, you'll contribute to advancing a diverse pipeline-from antibodies to oncolytic viruses to bispecifics. This role blends technical expertise, creativity, and leadership, offering exposure to both upstream and downstream operations and next-generation equipment. You'll tackle real-world challenges daily-troubleshooting, problem-solving, and innovating at the interface of biology and engineering. The pilot plant environment enables you to test and scale new technologies, support technology transfers, and deliver critical data for early and late-stage biologics. The ideal candidate brings a strong foundation in large-scale bioprocessing (upstream and downstream), proven leadership, and a track record of operational excellence-plus a curiosity for data science is a bonus. Join us to build the platforms of the future and make a lasting impact on patients worldwide. Your core scope of responsibilities will include managing new product introductions, leading team meetings, participating in experiment and equipment design, authoring, and reviewing standard operating procedures and manufacturing instructions, among other documents. **Other responsibilities include:** + Setup, execute, monitor, and troubleshoot cell culture, harvest, and purification operations up to the 500L pilot plant scale utilizing such equipment as rocking and single-use bioreactors, and single-use chromatography and filtration systems (TFF, VF, UFDF). + Perform in-process sampling and prepare buffers/media per defined manufacturing procedures as needed. + Pack and qualify chromatography columns up to 40 cm in diameter. + Document work in electronic lab notebooks per GDP principles while following appropriate SOPs. + Generate, analyze, and summarize process data to identify and mitigate challenges to future commercial processes, and support new technology development, new product introductions, and facility tech transfers. + Write, review & revise documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc). + Use digital tools such as Biovia Workbook, Emerson DeltaV, PI Vision, Smartsheet, Spotfire, Tableau, and the Microsoft suite (Outlook, Word, Excel, PowerPoint, Visio, SharePoint, Teams). + Maintaining an organized and clean workspace. + Identifying, recommending, and implementing improvements related to routine functions + Performing activities that include periods of rigorous, repetitive work. + Working safely around high-pressure systems and heavy equipment. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications. **Basic Qualifications:** + High school diploma / GED and 6 years of Scientific experience OR + Associate's degree and 4 years of Scientific experience OR + Bachelor's degree and 2 years of Scientific experience OR + Master's degree **Preferred Qualifications:** + Application of process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to everyday tasks. + Adherence to all regulatory requirements, written procedures, policies, and safety guidelines at all times. + Ability to organize work, handle multiple priorities, and meet deadlines. + Ability to interpret and apply GDP, FAIR, and ALCOA+ principles to everyday work. + Identify, recommend, and implement improvements related to routine functions (facilitate the drive towards continuous improvement in the plant). + Maintain an organized and clean workspace. Contributes to general housekeeping and 5S initiatives. + Demonstrates a sense of ownership and pride in work performed. + Demonstrate the Amgen Values and contribute to a culture of safety. + Ability to work in teams to complete operational tasks in a timely manner. + Creates a positive work environment through interactions with team members. + Ability to take initiative, follow up, ask questions and always act with honesty and integrity. + Ability to regularly lift up to 35 lbs, push and pull objects that require up to 50 lbs of force, and work on your feet for long durations. + Ability to perform physical movements to perform daily tasks on the production floor such as bending, reaching above the head, climbing, kneeling, squatting, stooping, walking up or down stairs, and standing on portable stairs or ladders up to 6 feet off the ground. + Ability to work some off-hours and weekends due to the nature of the work. **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, including remote and hybrid work arrangements, where possible **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Sponsorship** Sponsorship for this role is not guaranteed. 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.
Posted 2025-11-19

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