Senior Biologics PD Scientist – Analytical Lead

BioSpace; Thousand Oaks (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Retirement & Savings Plan

Comprehensive health benefits (medical

Dental & Vision

Job summary

Amgen is seeking a Process Development Sr Scientist to join the Thousand Oaks, CA team. You will provide strategic analytical leadership for late-stage and pivotal programs, guiding teams in method development, validation, and tech transfer to manufacturing and QA.

You will collaborate with Drug Substance/Product groups, oversee cross-functional analytics, author CMC sections, and drive process characterization and regulatory readiness in a fast-paced Biotech setting.

Qualifications

• PhD/MD/PharmD or equivalent and relevant post‑doc experience.

Responsibilities

• Supervise and provide technical support for a team that provides analytical support for late stage product development.
• Act as an Attribute Sciences Team lead for pivotal clinical process development programs.
• Define ATP for methods to monitor product quality and oversee method development, qualification, remediation, and transfer to QC.
• Manage activities at contract manufacturing and testing sites.
• Author regulatory documents’ analytical sections and respond to health authority questions.
• Drive product characterization to support process comparability studies and regulatory filings.
• Provide expertise on platforms and analytical technologies to improve Process Development.
• Help define strategies to improve department effectiveness and efficiency.

Skills

Analytical leadership

Cross-functional teamwork

Scientific writing

Regulatory knowledge

Communication skills

Problem solving

Adaptability

Education

PhD/PharmD/MD

MS with 3+ years scientific experience

BS with 5+ years scientific experience

Tools

Mass spectrometry

Biologics characterization (monoclonal antibodies, BiTEs)

HPLC (RP-HPLC, SEC, IEX)

CE (CE-SDS, cIEF)

Job description

Amgen is seeking a Process Development Sr Scientist to join the Thousand Oaks, CA team. You will provide strategic analytical leadership for late-stage and pivotal programs, guiding teams in method development, validation, and tech transfer to manufacturing and QA.

You will collaborate with Drug Substance/Product groups, oversee cross-functional analytics, author CMC sections, and drive process characterization and regulatory readiness in a fast-paced Biotech setting.