Senior Principal Scientist: Drug Product Process Development

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Benefits package

Flexible work model

Time-off plans

Job summary

Amgen is seeking a Process Development Senior Principal Scientist to lead and optimize drug product formulation and fill/finish processes across modalities. You will provide technical and project leadership, integrating cross-functional data to ensure successful commercialization and lifecycle management.

The role requires advanced degrees and substantial experience in pharma/biotech, with a strong emphasis on aseptic processing, regulatory interactions, and global transfers.

Qualifications

• Doctorate with 3+ years scientific experience or Masters with 6+ years or Bachelors with 8+ years.
• Advanced degree in Pharmaceutics, Biotechnology, Engineering or related field.
• 5+ years post-doctoral or industry experience in pharma/biotech.
• Experience with end-to-end development for liquid, lyophilized or oral solid dosage forms.
• Knowledge of regulations governing combination product development.
• Experience with parenteral biologics filling/characterization, scale-up, and manufacturing.
• Understanding of protein stability and stress effects on quality.
• Aseptic processing, cGMP, ICH guidelines, and pre-approval inspections.
• Experience with tech transfers to global sites, SPC, and DOE.
• Strong problem solving, interpersonal skills, and ability to influence.
• Experience supporting drug product development investigations and regulatory filings.
• Ability to learn quickly in a dynamic environment.

Responsibilities

• Lead drug product development studies for commercialization and lifecycle management.
• Support clinical and commercial fill/finish operations through analyses and investigations.
• Drive continuous improvement through innovation and first principles in process engineering.
• Lead global cross-functional teams to influence change and build strong relationships.
• Author and review guidelines, protocols, reports, regulatory submissions, and responses.
• Deliver progress reports to management on status and future needs.
• Utilize advanced IS systems to improve drug product design via data analysis.
• Travel domestically and internationally up to 10%.

Skills

Strong problem solving

Interpersonal skills

Influence colleagues

Education

PhD (Biologics/Pharmaceutics/related)

PharmD

MD

Masters degree

Bachelors degree

Tools

SPC

DOE/Design of Experiments

Job description

Amgen is seeking a Process Development Senior Principal Scientist to lead and optimize drug product formulation and fill/finish processes across modalities. You will provide technical and project leadership, integrating cross-functional data to ensure successful commercialization and lifecycle management.

The role requires advanced degrees and substantial experience in pharma/biotech, with a strong emphasis on aseptic processing, regulatory interactions, and global transfers.