Scientist Senior Engineer – Drug Product Process Engineering

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Scientist/ Senior Engineer Drug Product Process Engineering

Lets do this. Lets change the this vital role you will serve as Process Engineering Lead providing technical and project leadership for drug product formulation fill/finish inspection and presentation-specific activities. This role will integrate process product manufacturing quality regulatory and analytical information to ensure successful commercialization robust lifecycle management and reliable supply of assigned drug product SKUs.

The role will support clinical and commercial manufacturing operations technology transfers new product introductions process characterization process optimization and product impact assessments. The candidate will work closely with global cross-functional partners including Process Development Manufacturing Quality Regulatory Attribute Sciences Engineering Supply Chain and Commercial Operations.

This position may support Amgens global drug product manufacturing network including commercial sites contract manufacturing partners and internal development/manufacturing facilities. Domestic and international travel may be required.

Responsibilities:

• Serve as the Drug Product SKU Lead for assigned commercial or late-stage pipeline products providing end-to-end technical ownership for formulation fill/finish presentation and lifecycle management activities.
• Lead or support commercial technology transfers including facility-fit assessments make-a-batch assessments process gap analyses risk assessments process characterization studies technical documentation and on-site manufacturing support.
• Act as a Process Engineering Lead for parenteral drug product unit operations including formulation mixing sterile filtration filling capping lyophilization visual inspection and related equipment/process interfaces.
• Plan design execute and document laboratory offline and on-site studies related to drug product process development process characterization scale-up process robustness and lifecycle management.
• Provide technical leadership for assigned SKUs by integrating process understanding product quality attributes manufacturing performance analytical data regulatory commitments and site capabilities.
• Support clinical and commercial manufacturing operations through process capability analysis troubleshooting root cause analysis non-conformance investigations corrective and preventive actions and product impact assessments.
• Author and review technical protocols study reports process transfer documents product impact assessments regulatory submission sections responses to regulatory questions and lifecycle management documentation.
• Partner with manufacturing sites and cross-functional teams to assess and implement process changes equipment changes raw material changes scale changes site transfers and process improvements while ensuring product quality and supply continuity.
• Apply scientific and engineering principles including biochemistry biophysics statistics chemical engineering mechanical engineering automation and equipment design to solve complex technical challenges.
• Use data-driven approaches statistical analysis process monitoring modeling and advanced digital or AI-enabled tools to improve process understanding manufacturing robustness and technology transfer efficiency.
• Lead or participate in global cross-functional teams in a highly matrixed environment influencing decision-making communicating risks and driving alignment across stakeholders.
• Deliver clear technical updates progress reports risk assessments and recommendations to management program teams governance forums and manufacturing partners.
• Build and sustain strong partnerships with Drug Product Technologies Attribute Sciences Manufacturing Quality Regulatory Engineering Supply Chain and site teams to ensure alignment between product needs process requirements and site capabilities.

We are all different yet we all use our unique contributions to serve patients. The Scientific professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree
• OR
• Masters degree and 2 years of Operations Process Development Scientific or Engineering experience
• OR
• Bachelors degree and 4 years of Operations Process Development Scientific or Engineering experience

Preferred Qualifications:

• M.S. or Ph.D. in Chemical Engineering Biomedical Engineering Pharmaceutical Sciences Pharmaceutics Chemistry Biochemistry Biotechnology Material Science or a related technical discipline.
• 3 years of experience in drug product process development process engineering commercialization manufacturing sciences or lifecycle management within the pharmaceutical or biotechnology industry.
• Experience supporting parenteral drug product development and manufacturing including liquid and/or lyophilized presentations.
• Hands-on or technical experience with fill/finish unit operations such as formulation mixing sterile filtration filling capping lyophilization visual inspection and process scale-up.
• Experience serving as a technical lead SKU lead process lead or commercialization lead for late-stage or commercial drug product programs.
• Experience with process characterization scale-down model development scale-up technology transfer process validation support and commercial manufacturing support.
• Familiarity with aseptic processing cGMPs ICH guidelines regulatory filings pre-approval inspections and GMP documentation.
• Experience with non-conformance investigations root cause analysis product impact assessments process capability analysis statistical process control design of experiments and risk assessment tools.
• Strong understanding of how process parameters equipment raw materials scale site differences and process-related stresses can impact product quality.
• Ability to analyze large and complex data sets using statistical tools process monitoring approaches modeling or digital systems.
• Familiarity with AI-enabled tools or advanced analytics for process characterization process monitoring knowledge management and data-driven decision-making.
• Demonstrated ability to work effectively in a matrixed global team environment and influence across functions without direct authority.
• Strong communication technical writing facilitation organization and stakeholder-management skills.
• Ability to manage dynamic information prioritize across multiple programs or SKUs and drive decisions in a fast-paced environment.
• Ability to travel domestically and internationally as business needs require.

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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 or for field sales representatives a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range