• Job Description

  Req#: R-176903

  Career Category

  Scientific

  Job Description

  HOW MIGHT YOU DEFY IMAGINATION?

  You’ve 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

  Process Development Scientist

  Live

  What you will do

  Let’s do this! Let’s change the world! In this vital role you will work in our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and process development for biologics modalities. The Scientist will provide technical and project support, integrating effective cross-functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgen’s pipeline.

  The responsibilities of this candidate will include:

  • Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management

  • Design, plan, complete, and document formulation and process development studies

  • Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges

  • Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions

  • Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations

  • Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions

  • Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs

  • Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs.

  • Lead cross functional initiatives enhancing Pivotal Drug Product platforms

  • Manage and contribute to process design improvement projects

  • Ability to travel domestically and internationally up to 10% of the time

  Win

  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 employee with these qualifications.

  Basic Qualifications:

  Doctorate degree OR

  Master’s degree and 4 years of scientific experience OR

  Bachelor’s degree and 6 years of scientific experience

  Preferred Qualifications:

  • Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related field

  • Experience in pharmaceutical development and manufacturing

  • Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments

  • Experience with development and characterization of co-formulations

  • Experience with advanced drug delivery, e.g. sustained release technologies, targeted delivery systems, microfluidics

  • Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)

  • Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)

  • Critical thinking, problem solving and independent research skills

  • Strong project management skills, including the ability to manage one’s project resources (material, workforce, time, etc.)

  • Good organizational skills with strong attention to detail

  • Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally

  Thrive

  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

  Apply now

  for a career that defies imagination

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

  careers.amgen.com

  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.

  .

  Salary Range

  105,600.00 USD - 125,769.00 USD

• About the company

  Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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