Sr. Engineer Process Development

Career Category

Job Description

If you feel like you are part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.  

What you will do 

Reporting to the Principal Engineer of Process Development (Commercial Support), this person will be accountable for managing the Data Analytics / Process Monitoring group within the Commercial Support department, with additional responsibility for spearheading the digital transformation of the ADL Process Development organization at large. In this dynamic role you will lead the group responsible for ADL PD centralized analytics, liaise and develop relationships with key internal and network stakeholders, and provide technical & project leadership, all while coaching the adoption of practices related to integrating information generated by cross functional teams in the advancement of digital systems and applied data science at Amgen. Responsibilities will include:  

• Leadership and oversight of the Data Analytics / Process Monitoring group, with accountability for associated deliverables in control limit review / maintenance, monthly reporting, investigations, Annual Product Review summaries and maintenance of site monitoring plans and SOP’s.  

• People management and development of a specialized team of scientists / engineers, including the identification and adoption of practices required for the future growth of the organisation. 

• Engagement (and integration of business practices) with key internal & network stakeholders - acting as a critical member of global cross-functional teams, working effectively in a highly matrixed environment to drive change, increase efficiency, and foster strong relationships. 

• Utilising advanced IS systems to improve drug product transfers / commercial support by advancing data availability, leveragability, manageability (i.e. large data set integration), and automated analyses. 

• Working with the wider PD team to identify and implement digital opportunities, including the provision of guidance and training in application. 

• Executing high priority objectives supporting the advancement of Drug Product Technologies’ Digital Transformation initiatives.  

• Representing functional area requirements for digital platform development in support of production data systems. 

• Oversight of the authoring and reviewing of guideline documents, technical protocols, reports, procedures, and support responses to regulatory questions and audits in the context of digital systems. 

What we expect of you 

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek will have an aptitude for people management alongside knowledge and proficiency in the use of statistical analysis tools, continuous improvement methodologies, and problem-solving techniques. The candidate will also have proficiency in the equipment function and data collection associated with vial and syringe filling / inspection lines for biological drug product manufacture.  

Basic Qualifications: 

• Bachelors or Masters degree in Science, Engineering, data science or data analytics. 

• 6+ years experience in manufacturing environment (biotechnology, pharmaceutical, medical device or high volume manufacturing) using process data and statistical analysis to drive decision making (e.g. SPC trending, Nelson/WACO trend rules, process capability, etc). 

• Demonstrated leadership skills with the ability to operate across cross functional teams internal to the site and within the Amgen network. 

Preferred Qualifications: 

• Strong leadership skills with managerial experience directly managing people, teams, projects, and programs. 

• Demonstrated experience in parenteral drug product manufacturing and delivery of cross functional, complex technical projects. 

• Operational knowledge of development of commercial processes and process characterization, including the introduction and implementation of new technologies, with particular emphasis on the use of digital tools / in-silico modelling. 

• Strong problem-solving technical skills related to parenteral drug product manufacturing. 

• Thorough knowledge of GMP biotechnology manufacturing, with a significant understanding and knowledge of cGMPs. Experience with regulatory agency audits is beneficial. 

• Broad data science skill sets (e.g. statistics, advanced analytics, artificial intelligence (AI), and machine learning (ML)). 

• Demonstrated software development and/or software engineering skills. 

• Coding experience in Python, R, and/or SQL preferred. 

• Expertise in development of complex reporting solutions from data wrangling to final visualisations. 

• Familiarity with unit operations for oral and/or parenteral manufacturing (e.g. filling, filtration, mixing, etc.), specific scale-down model development, characterisation, and scale-up. 

• Self-motivated and enthusiastic to bring transformative digitalisation to the scientific community. 

• Strong problem solving and effective cross-functional communication skills. 

• Exceptional analytical abilities, including systems and design thinking. 

• Exceptional ability to work in a dynamic and collaborative team environment. 

About Amgen  

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.   

Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities—from training and education to expanding current job responsibilities. 

Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, colour, religion, sex, national origin, protected veteran status, or disability status.