Process Development Scientist

1 month ago

Rockville, United States Amgen Full time

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 Scientist (Formulation & Drug Product Development)Live

What you will do

Lets do this Lets change the world In this vital role you will support Formulation & Drug Product Development at Amgen's site in Rockville, MD. This group is responsible for drug product formulation and process development for biologics in Amgens Rare Disease Business Unit. Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgens drug product and process development.The responsibilities will include:

  • Perform formulation screening, characterization, and stability studies to assess and select stage-appropriate formulations of biologic products using a variety of analytical techniques
  • Develop technical project plans to generate comprehensive data packages in support of early molecule assessment and formulation development
  • Author and review guideline documents, technical protocols, and reports
  • Author and review sections in support of regulatory submissions
  • Manage multiple activities in parallel to drive project plans to completion, meeting project timelines and landmarks
  • 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 stakeholders on progress towards milestones and forthcoming program needs.
  • Ability to travel domestically and internationally up to 10% of the timeWin

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a strong collaborator with these qualifications.Basic Qualifications:

  • Bachelors degree and 4 years of Scientific experience OR
Masters degree and 2 years of Scientific experience ORDoctorate degreePreferred Qualifications:Advanced degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject areaKnowledge of protein chemistry, degradation pathways, and biophysical methods involved in characterization and formulation of proteinsKnowledge of/experience with formulation and process development for liquid and lyophilized drug productsCritical thinking, problem solving and independent research skillsStrong project management skills, including the ability to manage ones project resources (material, personnel, time, etc.)Strong verbal and written communication skills both within the organization as well as externallyGood organizational skills with strong attention to detailStrong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally.Experience in cGMP practices, regulatory filings, and IP strategies is preferredThrive

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply 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.

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