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Process Development Scientist – Commercial Support

2+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Posting Title: Process Development Scientist – Commercial Support

Location: Amgen (location unspecified)
Career Category: Process Development
Employee Subgroup: Salaried FT
Country/Region: Global


Amgen Job Description

At Amgen, we believe in something bigger. Our shared mission—to serve patients living with serious illnesses—drives everything we do. Since 1980, we’ve been pioneers in the biotech world, focused on delivering innovative medicines to patients. We specialize in four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, helping millions of patients each year. Join us to make a lasting impact on patients' lives and on your career.


Process Development Scientist – Commercial Support

What You Will Do:

Amgen is seeking a Process Development Scientist to support our Parenteral Drug Product manufacturing facility. You will play a critical role in developing, characterizing, and validating processes for biologic product filling into vials and syringes. In this role, you will gain hands-on experience with processes like buffer preparation, compounding, filtration, and product holds, as well as operating sophisticated equipment such as single-use and stainless-steel tanks, mixers, filtration systems, and filling lines.

Your responsibilities will extend to supporting a 24/7 operation, providing technical recommendations, conducting data analysis, troubleshooting, and evaluating product impact. You will also support new product introductions, process improvements, and technology acquisitions. Strong documentation skills are crucial for preparing reports for regulatory audits.

Key responsibilities include, but are not limited to:

  • Technical:

    • Design and execute experiments to optimize protein-based formulations and filling processes.
    • Evaluate and interpret results using strong statistical methodologies, providing recommendations based on scientific data.
    • Ensure compliance with protocols, guidelines, and regulations.
    • Develop strategies for process characterization and validation, aligning with company policies.
    • Lead process improvement projects to enhance productivity and efficiency.
    • Provide on-the-floor support for commercial operations, troubleshoot issues, and share knowledge with manufacturing teams.
    • Support technology transfers and lead research in complex areas.
    • Develop innovative solutions to process challenges using advanced technical principles.
  • General:

    • Ensure regular attendance to the workplace, with flexibility for non-standard shifts.
    • Develop and implement project plans in collaboration with cross-functional teams.
    • Communicate technical information internally and externally, including with regulatory agencies.
    • Contribute to or author scientific/technical documents, including reports, publications, and regulatory submissions.

What We Expect of You:

We seek an individual with the following qualifications:

  • Basic Qualifications:

    • Doctorate degree in a relevant field
    • OR
    • Master’s degree and 2 years of experience in Process Development or Technical Services
    • OR
    • Bachelor’s degree and 4 years of experience in Process Development or Technical Services
  • Preferred Qualifications:

    • Academic background in Life Sciences or Engineering (Biochemistry, Chemical Engineering, etc.).
    • Experience with protein science, formulation, and filling processes.
    • Knowledge of Process Monitoring and statistical tools (e.g., JMP, Minitab).
    • Experience with technology transfer and process validation life cycles.
    • Proven experience supporting deviations, product impact assessments, and floor support.
    • Bilingual in Spanish and English is a plus.
    • Strong communication, problem-solving, and project management skills.

What You Can Expect of Us:

At Amgen, we are committed to fostering the professional and personal growth of our employees. As an organization that develops life-changing treatments, we believe in taking care of our team.

In addition to base salary, Amgen offers a Total Rewards Plan with the following benefits:

  • Comprehensive employee benefits package, including:
    • Retirement and savings plans with generous company contributions
    • Group medical, dental, and vision coverage
    • Life and disability insurance
  • Discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans, including an annual site shutdown
  • Flexible work models, including remote work arrangements where possible

Apply Now

Join Amgen in creating a future where we help patients live longer, fuller, and healthier lives. Apply today and be part of a team that is making a difference.

[Apply Here]


Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected basis. We ensure reasonable accommodations for individuals with disabilities to participate in the job application process, perform essential job functions, and enjoy the benefits of employment. Please contact us to request accommodation.