Senior Process Development Engineer

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Process Development Engineer

What you will do

Let’s do this! Let’s change the world!

As part of Amgen’s Process Development organization, Drug Product Technologies (DPT) is seeking a highly motivated Senior Engineer to provide process development support to Amgen’s clinical and commercial sterile fill-finish manufacturing plant in Thousand Oaks, CA (ATO). The candidate will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation and continuous process verification. Periodic shift work or on call work is required.

Key Responsibilities:

New Product Introductions

• Leads or supports new product introductions and lifecycle changes into Amgen Thousand Oaks drug product manufacturing facility as the Process Development lead by integrating products’ process design and requirements with the site’s procedures and capabilities. Serves as the Process Development SME for these products following completion of the tech transfer.

• Collaborates with multiple plant functions to ensure the aseptic fill finish equipment and procedures that constitute the DP platform processes are fully characterized to enable efficient and successful tech transfers of Amgen’s clinical & commercial product portfolio.

• Acts as point contact to provide knowledge of clinical and commercial manufacturing site process capabilities and practices.

• Supports make-a-batch exercises to determine facility fit and identify gaps.

• Designs, implements and documents off-line and on-site DP characterization studies.

• Designs, plans, and provides floor support to engineering, machinability, and process performance qualifications (PPQ) runs required to ensure successful product commercialization.

• Author and/or own high-quality process technology transfer and other technical documents.

Process Validation & Regulatory Support

• Development of validation plans and supports execution of PPQs for commercial manufacturing. Authors, and reviews process validation protocols, assessments and reports within Amgen’s quality systems.

• Ensure site’s process validation business process adheres to global regulatory agency standards, Amgen’s quality requirements, other site policies and procedures, including safety and training.

• Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, review and submission process and be responsible for response to regulator questions as required and support pre-Licensure & GMP inspections in the plant.

Manufacturing Support

• Provide front line and independent process development expertise for clinical and commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and on-going commercial manufacturing.

• Lead or assist in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Solve issues with drug product processing technologies and equipment.

• Embodies the use of science-based methodologies to rigorously drive to true root cause, such that decisions are both timely, and supported by clear Claims / Reasons / Evidence-based reasoning, ensuring patient safety.

• Conducts risk assessment for drug product operations and propose / implement appropriate Corrective / Preventative Actions (CAPA) for continuous improvement.

• Collaborate with manufacturing as well as all support functions such as engineering, quality, and drug product technologies to provide robust and coordinated support to manufacturing.

• Identifies and implements new process improvements for current and new sterile operations for increased reliability, agility and efficiency in plant operations.

• Work with multi-functional teams conducting FMEAs, risk assessments, author technical protocols, reports and regulatory filing subsections and presenting on findings and project status.

• Influences and supports the establishment of robust tactical and strategic objectives related to visual inspection, with particular emphasis on the evolving state of regulatory expectations, and alignment within the Amgen network.

• Technical management and project portfolio management for various process improvement and new technology integration projects.

Aseptic DP Technology leadership

• Serve as SME in new DP manufacturing technologies introduced into B20 and work with global multi-functional teams for shared best practices and technical advancements across Amgen clinical and commercial fill-finish plants.

• Drive innovations in aseptic processes, technologies and techniques, all in alignment with evolving regulatory expectations and internal quality standards, leading to continuous improvement in GMP drug product manufacturing.

• Work with a team of engineers and individually to design, execute and document primary data packages related to new technology development, while demonstrating specific expertise in aseptic processing and unit operations characterization.

• Supports expansion projects by supporting equipment user requirements, FAT, Process Characterization and Validation in all sterile fill finish processing areas.

DP Network support

• Establishes strong working relationships with partner sites across DP Manufacturing network to foster the sharing of technical best practices, improvement opportunities and lessons learnt to deliver high-quality manufacturing processes.

• Acts as single Point of Contact (POC) to drug product teams to guide/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization and visual inspection.

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 2 years of Engineering and/or Operations experience OR

• Bachelor's Degree and 4 years of Engineering and/or Operations experience OR

• Associate's degree and 8 years of Engineering and/or Operations experience OR

• High school diploma/GED and 10 years of Engineering and/or Operations experience

Preferred Qualifications:

• Advanced degree in engineering, biotechnology, life sciences or related field

• 4+ years of experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites

• Demonstrated expertise in leading functional area deliverables from planning through completion, with measurable impact to business outcomes. Ability to set, and achieve, tactical and strategic goals in a dynamic manufacturing environment, with due considerations for competing priorities.

• Experience in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.

• Project management skills, including the ability to manage numerous projects and evaluate project resource requirements.

• Demonstrated ability in providing leadership to multi-functional teams to advance complex projects to completion and influencing decisions.

• Ability to lead innovation, collaborate in a multi-functional team environment, and act on dynamic information at a rapid pace

• Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports

• Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with limited oversight

• Capable of organizing and communicating complex technical concepts to enable business decisions

• Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).

• Demonstrated ability to use interpersonal skills to build strong technical relationships.

• Self-motivation, adaptability and a positive attitude.

• Excellent communication skills, both oral and written.

• Ability to elevate relevant issues to project lead and line-management.

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies.

What you can expect from us

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, we’ll 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, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

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Application deadline

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.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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