Job ID: R-114863
Location: Cambridge, MA, US
HOW MIGHT YOU DEFY IMAGINATION?
You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
Let's do this. Let's change the world.
Amgen is a biopharmaceutical leader founded on discovering, developing, manufacturing, and delivering human therapeutics. The Biosimilars Business Unit Process Development (BBU-PD) is a dynamic group that works with a diverse range of cross-functional groups to develop Amgen biosimilar products by evaluating them for analytical similarity, a foundation of the biosimilar regulatory pathway. Within this group, the analytical data management team ensures that all analytical data generated is appropriately handled from acquisition through transcription into regulatory filings. This team also works with internal departments and external CROs and provides data management support and training.
In this vital role you will provide data management support for the entire biosimilar portfolio through technical expertise in both data science and statistics. Responsibilities will include compiling analytical data from multiple data systems, identifying and resolving data errors, providing interim analysis of the data as needed, identifying opportunities for improving data management practices, and training internal and external groups on best practices. The position offers the opportunity to engage with biosimilar process development from end to end for a wide range of products with diverse modalities and unique challenges.
This role will work with team members in both Cambridge and Thousand Oaks and can work remotely if needed.
- Support comprehensive compilation of analytical data for use in regulatory filings and provide responses to agency questions as needed.
- Act as a main point of contact for analytical data management, and interface between generators of analytical data, business partners, and statisticians.
- Assist team with routine analytical data reports for continuous data monitoring.
- Work routinely with quality control, quality engineering, research, analytical sciences, and CRO's to ensure proper data entry, handling, and exporting.
- Oversee improvement initiatives to data systems and to business processes to expand the team's data management capabilities.
- Detect, evaluate, and resolve errors in data systems, and seek solutions to prevent similar issues.
- Provide backup support as needed for sample login, data entry, database templating, document authoring, and related routine and non-routine tasks.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.
Master's degree and 3 years of data science, analytical chemistry, data engineering, or related field experience
Bachelor's degree and 5 years of data science, analytical chemistry, data engineering, or related field experience
Associate's degree and 10 years of data science, analytical chemistry, data engineering, or related field experience
High school diploma / GED and 12 years of data science, analytical chemistry, data engineering, or related field experience
- Experience in a Biotech/Pharma Process Development, Informatics, and/or Quality Engineering role.
- Experience with joining, pivoting, and presenting disparate data sets.
- Advanced knowledge with Excel, including macro creation and VBA programming.
- Experience with statistical and data analytics tools such as SAS, Spotfire, and JMP.
- Experience with data structures, database administration, and/or SQL programming.
- Experience with electronic lab notebooks and inventory management systems such as Holistic Labs and LIMS.
- Understanding of analytical chemistry, immunology, and/or functional biology.
- Experience working in or around analytical testing labs and research organizations.
- Understanding of data science and statistics principals and able to communicate concepts to laypeople.
- Understanding of regulatory requirements such as good data practices and data verification.
- Ability to gather and communicate business requirements for system and process improvements.
- Strong technical writing and procedure documentation skills.
- Demonstrated ability to work under minimal direction.
- Able to adapt to changing business needs and operational requirements.
- Able to multi-task and function in a dynamic environment.
- Able to deliver high quality results in a timely manner.
- Excellent written and verbal communication skills.
- Strong leadership skills and decision-making abilities.
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a 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 an accommodation.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.