Process Development Associate Scientist Full-time NEW

Process Development Associate Scientist

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.

As part of Amgen's Process Development organization, Drug Product Technologies (DPT) is seeking a highly dynamic Process Development Associate Scientist with expertise in syringe/vial filling operations to support Amgen's clinical and commercial sterile fill-finish manufacturing site in Thousand Oaks, CA. You will play a key role in ensuring robust aseptic processing, seamless technology transfer, process characterization, validation, and continuous verification—helping bring high-quality medicines to patients worldwide.

Key Responsibilities:

• Lead and implement characterization studies on the floor including fill recipe development for syringes and vials, process characterization, tech transfer studies, process validation, and ongoing commercial manufacturing.
• Lead or assist in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Address issues with drug product processing technologies and equipment.
• Conducts risk assessment for drug product operations and propose / implement appropriate CAPA for continuous improvement.
• Collaborate with manufacturing as well as all support functions such as engineering, quality, and drug product technologies to provide robust and coordinated support to manufacturing.
• Identifies and implements new process improvements for current and new sterile operations for increased reliability, agility and efficiency in plant operations.
• Work with multi-functional teams conducting FMEAs, risk assessments, author technical protocols, reports and CMC subsections and present findings and project status.

Aseptic DP Technology Leadership:

• Serve as SME in introducing new DP manufacturing technologies in the ATO site and work with global multi-functional teams for shared standard processes in technical advancements across Amgen clinical and commercial fill-finish plants.
• Drive innovations in aseptic processes, technologies and techniques, all in alignment with evolving regulatory expectations and internal quality standards, leading to continuous improvement in GMP drug product manufacturing.
• Work individually and with a team of engineers to design, implement and document primary data packages related to new technology development, while demonstrating specific expertise in aseptic processing and unit operations characterization.
• Supports expansion projects by supporting equipment user requirements, FAT, Process Characterization and Validation in all sterile fill finish processing areas.

DP Network Support:

• Establishes strong working relationships with partner sites across DP Manufacturing network to champion the sharing of technical standards, improvement opportunities and lessons learned to deliver high-quality manufacturing processes.
• Acts as Point of Contact (POC) to drug product teams to guide/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization and inspection.

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:

• Master's degree and 1 year of Scientific, Engineering and/or Operations experience OR
• Bachelor's degree and 3 years of Scientific, Engineering and/or Operations experience

Preferred Qualifications:

• Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology or related technical field of study in biotechnology, life sciences or related field.
• 3+ years of experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites
• Experience in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
• Project management skills, including the ability to handle numerous projects and evaluate project resource requirements.
• Demonstrated ability in providing leadership to multi-functional teams to advance complex projects to completion and influencing decisions.
• Ability to lead innovation, collaborate in a multi-functional team environment, and act on dynamic information at a rapid pace.
• Ability to independently design and implement characterization studies, author characterization protocols, process transfer documents, application notes and technical reports.
• Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with limited oversight.
• Capable of organizing and communicating complex technical concepts to enable business decisions.
• Solid understanding of Quality systems and Drug Product Manufacturing (GMP).
• Demonstrated ability to use interpersonal skills to build strong technical relationships.
• Self-motivation, adaptability and a positive demeanor.
• Excellent communication skills, both oral and written.
• Ability to elevate relevant issues to project lead and line-management.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies.

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.