Process Development Associate Scientist - Amgen

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Process Development Associate Scientist

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What you will do

Lets do this! Lets change the world! In this vital role you will apply scientific and engineering principles to advance the technical aspects of Amgens drug product and process development.

• Work as a part of a visual inspection team within Amgen, liaise with cross-functional stakeholders and a global network to manage inspection methods, equipment (such as Automatic Visual Inspection), and processes.
• Participate in the planning, design, completion, and documentation of studies related to drug product manufacturing and process development in support of the commercialization and life cycle management of biologic therapeutics.
• Provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations, process changes/improvements, and regulatory inspections.
• Support manufacturing operations / investigations from a product impact perspective.
• Author and review technical protocols, reports, and regulatory sections in support of submissions.
• Evaluate process performance through statistical methodology / trending review and reporting on associated feedback.
• Actively utilize IS systems to improve drug product processing through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
• Build visualizations to enable business application of data analysis.
• Explore and evaluate new digital tools and techniques to improve the teams developmental and operational capabilities.
• Participate in global cross-functional teams working efficiently in a highly matrixed environment to progress product development.
• Support standardization and improvements of departmental practices by adding to guideline documents.
• Deliver progress reports and presentations to ensure management awareness and engagement of current status, progress, and future program and functional needs.

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 a Scientist with these qualifications.

• Bachelors degree and 3 years of scientific experience OR
• Masters degree and 1 year of scientific experience

• Masters degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related field.
• 4+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments.
• Experience with drug product unit operation (i.e. formulation, filling, filtration, mixing, etc.) specific to visual inspection requirements.
• Experience with regulatory filings and compliance issues.
• Experience in at least one statistical software package (such as SIMCA or JMP).
• Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function.
• Experience with Vision system
• Strong problem solving and effective cross-functional interpersonal skills.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Established ability to learn and act on dynamic information at a rapid pace.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Objects in your future are closer than they appear. Join us.

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 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.