HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Process Development Scientist Attribute Sciences
What you will do
Lets do this. Lets change the world! In this vital role You will act as the Attribute Science Team Leader (ASTL) in support to Commercial Operations. This role will manage a portfolio of product projects, develops experimental strategies and/or leads these activities. Provides input to new processes to generate robust, and reliable data. In addition, functions as a lead scientific / technical resource or as a project leader with cross-functional impact.
With our state-of-the-art facilities, this team also collaborates and closely work with Amgens manufacturing network to ensure innovation is incorporated into our processes and ensure product delivery. We are a highly dedicated team that uses our strength in cell sciences and upstream operations in support of our role serving patients.
Specific responsibilities include but are not limited to:
Monitors or conducts experiments, studies, or manage a series team of experiments/studies to advance projects or technologies.
Assesses impact of data on the project to make recommendations and be a key contributor to an independent research/project team.
Prepares new and novel protocols/experimental design.
Act as scientific/technical expert within the function and leads the development of scientific strategies.
Analyze and interpret analytical data to support product development (for Process Development, Quality, etc.), investigations and regulatory submissions and response-to-questions.
Participates or contributes to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation, and data interpretation.
Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, and expected results.
Guides the successful completion of major programs by either functioning in a project leadership role or as the scientific/technical resource lead.
Provides guidance and recommendations in the resolution of scientific/technical issues and integrates activities with other functions/departments.
Evaluates progress toward goals and achievement of milestones for work group and translates evaluation into appropriate action.
Communicates and/or presents scientific/technical information formally and informally within area of expertise to a diverse set of audiences, including senior management.
Client orientation establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered.
Develop and apply characterization strategies to drug substance and drug product comparability studies, characterization of product degradation pathways, and reference standard characterization.
Focus on developing technologies to reduce cost of quality, implementation of methods in Quality Control (QC).
Application of product characterization, including primary structure / glycan structure elucidation, determination of product purity profiles, product attribute criticality and target product profiles, process characterization and product testing.
Generation of technical documents and presentations as assistance in the preparation of relevant sections of regulatory documents.
Working as part of a cross-functional team to define strategies for performing complex data analyses and setting of acceptance criteria in support of process/product development, process/method transfers, and comparability studies.
Keeping current with field of expertise, commercial process regulations, including literature and technology development.
Develops and follows timelines for completing project with different teams.
Support non-standard shift operations including extended hours, as per business needs.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients! The Process Development Scientist professional we seek is an Individual Contributor Leader with these qualifications.
Masters degree & 4 years of Scientific or Laboratory experience
Bachelors degree & 6 years of Scientific or Laboratory experience
Beyond that, additional preferred qualifications are:
Educational background in Life Science: Biological and/or Analytical sciences.
Expertise with proteins, peptides and glycans.
3+ years of expereince providing support to analytical testing laboratories.
Expertise in analytical assay development (method characterization, qualification, validation, technical transfer).
Analytical technical expertise in protein biologics or small molecules.
Good problem-solving skills requiring the application of scientific theory.
Ability to demonstrate skills in independently determining and developing scientific analysis and solutions, as well as demonstrate strong laboratory work skills to include the design and performance of scientific experiments and interpretation of results.
Ability to work collaboratively with other Scientists on multidisciplinary teams.
Computer literacy (Windows environment: Word, Excel, Power Point).
Excellent presentation and communication skills (verbal and written) in English and Spanish.
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us: careers.amgen.com
Join UsIf 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.
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.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.