Senior Engineer Drug Substance Technology & 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease obesity and obesity-related conditions rare diseases inflammatory conditions and cancer. 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.

Senior Engineer

Lets do this. Lets change the this vital role you will provide downstream purification manufacturing support supporting a diverse portfolio of both clinical and commercial biologics drug substance products. You will provide engineering oversight and play a key role in early phase technology transfer and the manufacturing execution process optimization and strategic improvement initiatives across all phases of development and the commercialization lifecycle.

The role combines hands-on technical leadership with direct people management. You will work with a cross functional group of engineers and scientists through the process development cycle at Amgen and contract site(s) to ensure successful technology transfer manufacturing and regulatory support. You will also use your engineering experience in the oversight and operations of production facilities; including process execution equipment utilization and optimization. Additionally you will directly manage and develop other downstream process engineers and guide manufacturing execution on-floor escalation support process monitoring complex investigations and process improvement across downstream purification operations.

You will build productive partnerships with Manufacturing Quality Process Development Validation Regulatory Facilities and Engineering Supply Chain and network teams in support of a highly dynamic manufacturing facility. Limited domestic and international travel may be necessary at times.

The ideal candidate should be well versed in tech transfer process development scale up modeling optimization characterization regulatory support and GMP commercial production.

Lead technical support for cGMP clinical and commercial downstream purification processes including harvest and clarification chromatography viral filtration UF/DF and sterile filtration.

Initiate and execute technology transfer and manufacturing support activities including process transfer documentation process and facility-fit assessments risk analyses manufacturing readiness activities and process documentation.

Represent DSTE on cross-functional teams to ensure deliverables supporting technology transfer manufacturing execution investigations and process improvements are completed on schedule.

Provide on-floor manufacturing support and technical escalation support to enable safe compliant and reliable manufacturing execution.

Routinely monitor process and operational performance using relevant manufacturing process and product data. Lead problem resolution and provide troubleshooting guidance for process performance issues.

Apply engineering principles statistical analysis and design of experiments as appropriate to investigate processing issues identify process risks and evaluate process improvement opportunities.

Lead or support deviations investigations root-cause analyses CAPAs change controls and risk assessments. Develop timely controls and effective actions that reduce recurrence.

Evaluate select and apply appropriate engineering techniques and procedures to resolve technical process equipment and manufacturing issues.

Partner with Process Development to ensure processes are robust scalable and designed to consistently deliver required product quality attributes and enable manufacturing success.

Collaborate with Manufacturing Quality Process Development Validation Regulatory Supply Chain Facilities and Engineering and network drug substance teams to deliver technical solutions and achieve plant and project objectives.

Author review and maintain technical documentation including protocols reports process assessments standard operating procedures batch record support documents and engineering assessments.

Contribute to process validation PPQ continued process verification process monitoring regulatory filings inspections and other CMC activities as needed.

Ensure manufacturing operations are aligned with the registered process applicable cGMP requirements site procedures and established safety and quality standards.

Lead cross-functional problem-solving efforts while balancing quality schedule cost and operational considerations.

Share technical expertise and mentor less experienced engineers in downstream process knowledge troubleshooting data analysis and manufacturing support practices.

Leadership:

Ensures that safe practices are followed.

Provides mentoring and expertise to staff on the downstream team.

Develop high-performing engineers by coaching through complex technical decisions investigations and project delivery while encouraging independent problem solving and sound judgment.

Collaborates within the department and interdepartmentally.

Provides scientific and technical leadership.

Ensure department staff are adequately developed and trained.

Initiates and encourages scientific collaboration with groups outside the department.

Build and maintain effective collaborations with partner organizations.

Anticipates proactively detects and addresses problems related to departmental and interdepartmental activities.

Inform and consults department head and senior staff appropriately

We are all different yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Basic Qualifications:

Doctorate degree
OR
Masters degree and 2 years of Engineering experience
OR
Bachelors degree and 4 years of Engineering experience
OR
Associates degree and 8 years of Engineering experience
OR
High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications:

Engineer with 5 years of experience in downstream purification and providing and driving engineering deliverables for pharmaceutical processes and product development.

2 years of experience directly managing people and/or leadership experience leading teams projects and programs or directing the allocation of resources.

Demonstrates technical leadership of cross-functional teams projects or programs including the ability to influence decisions and coordinate work across competing priorities.

Strong in-depth expertise in downstream purification processes and commercial biologics manufacturing operations.

Experience supporting process development scale-up technology transfer process validation PPQ continued process verification and manufacturing execution.

Strong understanding of cGMP regulatory safety and quality requirements including experience supporting regulatory filings inspections and product lifecycle activities.

Ability to apply engineering principles statistical analysis analytical methods and process data to troubleshoot processing issues evaluate product and process performance and identify improvement opportunities.

Experience with process monitoring Quality by Design Process Analytical Technology process modeling or data visualization tools used to support biological processing.

Ability to critically evaluate biological processes and manufacturing systems to identify process improvements scale-up considerations technology transfer risks and facility-fit requirements.

Strong written verbal and presentation skills with the ability to communicate complex technical information effectively to diverse stakeholders.

Demonstrated teamwork mature process-fit assessment skills and a strong understanding of plant safety practices.

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 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. We make all employment decisions without regard to race color religion sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities consistent with legal requirements. Please contact us to request accommodation.

Salary Range