Career CategoryProcess Development
Job DescriptionProcess Development Scientist - Commercial SupportWhat you will do Let's do this. Let's change the world! In this vital role, you will join the team to provide support to Amgen's parenteral manufacturing plant. You will contribute to process monitoring , process improvement, investigations, technology transfers, and other projects that support reliable manufacturing and delivery of life-changing therapies to patients.
Specific responsibilities include but are not limited to:- Support process monitoring, improvement initiatives, technology transfers, and implementation of data-driven solutions for Formulation, and aseptic Drug Product manufacturing processes.
- Assist with deviations investigations, root cause analysis, product impact assessment and corrective and preventive action implementation.
- Author and contribute to technical documents, protocols, reports, presentations, and regulatory-support documentation.
- Maintain awareness of relevant scientific literature, technology developments, and internal best practices, and communicate observations to project teams.
- Collaborate cross-functionally with Manufacturing, Quality, Engineering, Process Development, and other internal partners to support commercial manufacturing.
- Perform data analysis, and provide technical conclusions, and recommendations to internal teams.
- Ensure all work is performed in compliance with applicable safety, quality, regulatory, and cGMP expectations.
- Support department initiatives such as safety programs, continuous improvement activities, , training, and knowledge-sharing forums, as appropriate.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Process Development Scientist professional we seek is a collaborative and technically strong individual contributor with these qualifications.
Basic Qualifications:Doctorate degree
OR
Master's degree and 2 years of scientific, process development, laboratory, or manufacturing support experience
OR
Bachelor's degree and 4 years of scientific, process development, laboratory, or manufacturing support experience
Preferred Qualifications:- Educational background in Life Sciences, Biotechnology, Chemical Engineering, Biochemical Engineering, Biology, Chemistry, or a related engineering or scientific discipline.
- Understanding of protein science, formulation and filling processes.
- Relevant experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
- Excellent communication, presentation, problem-solving, project management skills and cross-functional collaboration skills.
- Understanding of regulated manufacturing environments, cGMPs, quality systems, and regulatory expectations.
- Experience supporting deviation investigations, troubleshooting, root cause analysis, product Impact Assessments, , and corrective action implementation.
- Strong technical skills, including scientific analysis, data interpretation, statistical analysis (e.g., JMP software), and problem solving.
- Ability to evaluate process performance and apply data-driven approaches to process monitoring, data trending, technical decision-making, and continuous improvement.
- Strong organizational skills, with the ability to manage priorities, document work clearly, and meet project timelines.
- Effective communication skills, including technical writing and presentation of scientific information to cross-functional teams.
- Experience preparing documentation for regulatory audits and submissions.Bilingual communication skills in English and Spanish, written and verbal.
- Ability to collaborate effectively across functions and adapt to changing business needs.
- Flexibility to provide manufacturing floor support in a fast-paces 24/7 operation, including non-standard shifts, on-call activities, or manufacturing operations, as required by business needs.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
- 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
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team. careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information
SponsorshipSponsorship for this role is not guaranteed.
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