Assoc Director of Engineering Platform Technical Lead Mechanical Autoinjectors

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Job Description

Join Amgens Mission of Serving Patients

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. 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 awardwinning 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.

Assoc. Director of Engineering Platform Technical Lead: Mechanical Autoinjectors

What you will do

Lets do this! Lets change the world! We are currently seeking an Associate Director of Engineering Platform Technical Lead for our Mechanical Autoinjector Platform. As part of the Combination Product Development (CPD) group this role will support technical teams in the successful design testing manufacturing and commercial sustainment of mechanical drug delivery devices for Amgen combination products. The Associate Director of Engineering will collaborate with global team members across systems engineering process engineering device development packaging primary containers device quality product delivery teams and other groups.

In this role the Associate Director will lead the testing design transfer postmarket surveillance and life cycle management of multiple autoinjector device commercialization efforts. This includes overseeing engineering characterization and GMP verification testing while ensuring alignment with project goals and timelines. The position requires close collaboration with suppliers to enable capacity expansions and evaluate new design changes and improvements and it demands strong technical background in mechanical engineering and functional leadership of technical teams focused on device design testing manufacturing and regulatory compliance.

The role also requires ensuring compliance with regulatory requirements and quality standards for combination product technologies while driving the continuous improvement of processes methods and tools used in the development and life cycle management of mechanical autoinjector devices. The Associate Director will oversee the creation of technical documentation including test plans protocols reports and regulatory submissions and ensure alignment of project timelines resource allocation and risk management for successful device commercialization. They will also monitor and assess the lifecycle of mechanical autoinjector devices to ensure postmarket performance and regulatory compliance.

Furthermore the Associate Director will play a key role in supplier management ensuring that quality and technical specifications are met at all stages of product development and supply. They will provide support to the manufacturing network by ensuring efficient production processes and resolving any technical issues that arise during manufacturing. In addition they will support agency inspections and respond to Regulatory Technical Queries (RTQs) collaborating with regulatory and product teams to ensure timely and accurate responses to inspection findings or queries.

This role requires strong proficiency in technical team management mechanical design drug combination product technologies and regulatory requirements. The successful candidate will be expected to collaborate with vendors and Amgen suppliers to facilitate the accurate planning and of design activities.

• Provide leadership oversight and overall representation to Amgens Mechanical Autoinjector Combination Product platform

• Proficiency in Fit to Platform Assessments Product Technical Review and Lifecycle management product strategies

• Identify product issues/opportunities for in scope device platforms and drive solutions for cross product implementation (within CPO Product delivery and Supply Chain organizations)

• Consider platform boundaries across operations commercial and regulatory labeling

• Support appropriate prioritizing of programs including product lifecycle management and compliance related activities

• Direct management of professional engineering team responsible for technical assignments and life cycle management activities

• Estimated travel is 1020

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:

• High school diploma / GED and 14 Engineering years of experience OR

• Associates degree and 12 years of Engineering experience OR

• Bachelors degree and 9 years of Engineering experience OR

• Masters degree and 7 years of Engineering experience OR

• Doctorate degree and 3 years of Engineering experience

In addition to meeting at least one of the above requirements you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• M.S. in Mechanical Engineering Material Sciences or related areas experience with 6 years of experience in the Medical Device industry and Pharmaceutical Industry

• Combination product experience (Drug Product and/or Medical Devices)

• Leadership experience in building and developing successful teams delivering results and shaping the future

• Strong problemsolving skills with the ability to be a clear thinker work through complex problems and determine an end solution

• Allocate resources prioritize activities and manage multiple partners to support leaders across the business including working with leaders across functions

• Business acumen that lends itself to understanding the context and dynamics of pharmaceutical challenges that impact Platform alignment

• Partners with business leaders to deliver highquality outcomes using strategic decision making (DAI)

• Thinks strategically about issues impacting an entire portfolio of therapeutics versus Platform adherence

• Direct or Indirect staff management experience; including performance management hiring and onboarding and staff development

• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment

• Experience with the fill finish manufacturing process (glass/elastomers/polymers) device assembly and packaging for medical (aseptic) applications

• A passion to deliver excellent work product develop others with an infective positive attitude

• Ability to travel / 20 of time

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

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

In any materials you submit you may redact or remove ageidentifying 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.

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.

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