Process Development Scientist - Global Method Implementation Team (Gmit)

4+ years

107,234.00 USD - 129,162.00 USD

Thousand Oaks

10 Jan. 8, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Title: Process Development Scientist – Global Method Implementation Team (GMIT)

Location: Flexible (with minimal travel, ~10%)
Company: Amgen

Join Amgen’s Mission of Serving Patients

At Amgen, being part of something bigger drives us. Since 1980, we’ve pioneered biotechnology to tackle the world’s toughest diseases. Focused on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions annually with innovative treatments.

Our collaborative and science-based culture supports tackling challenges with enthusiasm. Transform lives, including your own, by joining the Amgen team.

What You Will Do

As a Process Development Scientist in the Global Method Implementation Team (GMIT), you will support Amgen’s late-stage programs by driving innovative strategies and robust analytical method implementation. GMIT ensures method transfer and validation across a multimodality portfolio, advancing programs from clinical trials to commercialization and post-launch.

Key Responsibilities:

Support complex method implementation projects with minimal supervision to enable successful global regulatory filings.
Develop and support technical strategies, communicate challenges, and collaborate on solutions.
Contribute to regulatory documentation for filings, inspections, and partner engagements.
Foster team collaboration and promote continuous improvement of method implementation processes.
Work within a matrixed organization to track and communicate project progress effectively.
Partner with Process Development, Manufacturing, and Quality teams to ensure seamless execution.

What We Expect of You

We seek a dynamic scientist with expertise in analytical method implementation, a passion for innovation, and a drive to serve patients.

Basic Qualifications:

Bachelor’s degree and 4 years of relevant experience OR
Master’s degree and 2 years of relevant experience OR
Doctorate degree

Preferred Qualifications:

Degree in Bioanalytical Chemistry, Analytical Chemistry, Biochemistry, Biochemical or Chemical Engineering, or other biological sciences.
Strong knowledge of analytical methods/technologies (e.g., Chromatography, Bioassay, PCR, Microbiology, Immunoassay, CE, Gel).
Hands-on experience with method validation and transfer for clinical and commercial programs in compliance with ICH Q2 guidelines.
Familiarity with regulatory expectations for analytical control and method implementation.
Understanding of product quality attributes, control strategies, and CMC processes.
Strong data analysis and interpretation skills, including statistical methods.
Experience with regulatory filings and regulatory agency interactions.
Growth mindset, innovation, and a commitment to continuous improvement.
Effective communication, collaboration, and project management skills.

What You Can Expect from Us

At Amgen, we prioritize your professional growth and well-being with competitive benefits and a collaborative environment.

Benefits Include:

Comprehensive Benefits: Medical, dental, vision, life, and disability insurance.
Retirement Plans: Generous contributions to retirement savings.
Incentives: Annual bonus or sales-based incentive programs.
Stock Options: Long-term stock-based incentives.
Flexible Work Models: Remote and hybrid options, where possible.
Career Development: Opportunities for growth and skill development.
Award-Winning Time-Off Plans.

Apply Now

Transform your career while transforming lives. Apply today to join a team revolutionizing method implementation in the biotech industry.

Website: careers.amgen.com

Amgen’s Commitment to Inclusion

Amgen is an Equal Opportunity Employer, fostering an inclusive and diverse workplace. We ensure reasonable accommodations for individuals with disabilities throughout the hiring process.

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

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Process Development Scientist - Global Method Implementation Team (Gmit)

Job Description

Job Title: Process Development Scientist – Global Method Implementation Team (GMIT)

Join Amgen’s Mission of Serving Patients

What You Will Do

Key Responsibilities:

What We Expect of You

Basic Qualifications:

Preferred Qualifications:

What You Can Expect from Us

Benefits Include:

Apply Now

Amgen’s Commitment to Inclusion

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