Senior Principal Scientist, Process Development

Amgen

. Serve as a leader on Drug Product Commercialization Teams planning, designing, executing, and documenting laboratory studies for drug product design, formulation, and process development .

Posted 11/6/2026full-timeUnited StatesSenior💰 $157,737 - $213,409 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in drug product commercialization, process development, and regulatory submissions, with a strong emphasis on leadership and cross-functional collaboration. Proficient in statistical analysis and process capability to enhance drug product design and manufacturing operations.

Highest-signal resume keywords

Drug Product CommercializationProcess DevelopmentRegulatory SubmissionsAseptic ProcessingStatistical Process Control

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Drug Product DesignFormulation DevelopmentProcess Capability AnalysisTechnical Protocol AuthoringStatistical AnalysisProcess CharacterizationSingle-Use Manufacturing EquipmentLyophilized Drug ProductsCGMP ComplianceICH Guidelines

Soft Skills

People-Centered LeadershipEffective CommunicationProblem SolvingTeam CollaborationAdaptability

Tools & Technologies

Advanced Information SystemsLarge-Data AnalysisStatistical Design of Experiments

Industry Keywords

PharmaceuticalsBiotechnologyClinical ManufacturingCommercial Fill/FinishRegulatory Questions

About the role

Key responsibilities & impact

Serve as a leader on Drug Product Commercialization Teams planning, designing, executing, and documenting laboratory studies for drug product design, formulation, and process development
Support commercialization and lifecycle management of parenteral presentations
Lead a team of scientists focused on late-stage drug product process development and technology transfer
Coach staff with emphasis on people-centered leadership
Support clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments
Drive continuous improvement through technological innovation and first-principles process engineering
Participate in and lead global cross-functional teams to drive change and efficiency
Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions
Develop responses to regulatory questions
Deliver progress reports and presentations to management
Use advanced information systems, historical data, large-data analysis, and statistical analysis to improve drug product design
Serve as Drug Product Team Leader and single point of accountability for commercial drug product programs

Requirements

What you’ll need

Doctorate degree (PhD, PharmD, or MD) and 3 years of engineering or science experience, or Master’s degree and 6 years of engineering or science experience, or Bachelor’s degree and 8 years of engineering or science experience
Advanced degree in Pharmaceutics, Biotechnology, Engineering or related discipline and industry experience in pharmaceuticals/biotechnology
Demonstrated knowledge of drug product commercialization and integrated combination product development
Hands-on experience with end-to-end development for liquid, lyophilized and/or oral solid dosage drug products in various presentations
Demonstrated experience in process transfers, control strategy, authoring MAs, developing robust responses to regulatory questions, supporting validation activities and PAIs at commercial sites
Understanding of physical/chemical stability of proteins and the impact of freezing and drying on short- and long-term stability
Strong knowledge of developing processes with single-use manufacturing equipment
Aseptic processing experience and familiarity with cGMPs and ICH guidelines
Experience with new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
Strong problem solving and effective cross-functional communication skills
Ability to learn and act on dynamic information at a rapid pace
Ability to participate in global cross-functional teams and work effectively in a highly matrixed environment
Ability to travel domestically and internationally up to 10% of the time

Benefits

Comp & perks

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities
Work/life balance
Financial plans with opportunities to save towards retirement or other goals