Director Engineering - Clinical and Platform Secondary Packaging

Career Category

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.

Director Engineering Clinical and Platform Secondary Packaging

What you will do

Lets do this. Lets change the world. In this vital role you will lead all aspects of the packaging processes for clinical trial materials and platform packaging which are key to enabling commercialization of Amgens pipeline ensuring that they meet regulatory requirements protect product integrity and facilitate effective clinical distribution. The Director is a key player in maintaining the highest standards of quality efficiency and compliance within the packaging operations.

• Leading a team of packaging professionals providing guidance training and development opportunities to ensure optimal performance.

• Ensuring all packaging processes comply with regulatory standards such as Good Manufacturing Practices (GMP) Good Clinical Practices (GCP) and other relevant guidelines.

• Quality: Implementing rigorous quality measures to ensure the robustness consistency integrity and safety of packaging for clinical trials and commercial products.

• Process Optimization: Continuously improving procedures to enhance efficiency reduce costs and minimize waste.

• Materials Science and Engineering: Lead the evaluation and define fundamental requirements and evaluation for paper (natural fiber based) polymer adhesives clandestine security features and ink.

• Coordination: Collaborating with other departments such as Clinical Operations External Supply Chain and Regulatory Affairs to ensure seamless integration of packaging processes.

• Innovation: Staying abreast of new packaging technologies and trends and integrating innovative solutions to improve packaging operations.

• Technology management of materials and engineering standards which enable both modeling and rapid evaluation of new or alternate materials (Paper and Polymer/Adhesives) and modeling

• Oversight of pilot facilities to characterize and improve specifications and standards that enable rapid deployment to commercial facilities

• Collaboration with Human Factors to enhance our patient experience with a design for manufacturability approach

What we expect of you

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

Basic Qualifications:

Doctorate Degree and 4 years of leadership in a regulated industry and/or engineering/materials science relevant experience

Or

Masters degree and 8 years of leadership in a regulated industry and/or engineering/materials science relevant experience

Or

Bachelors degree and 10 years of leadership in a regulated industry and/or engineering/materials science relevant experience

In addition to meeting at least one of the above requirements you must have at least 4 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:

• A degree in Mechanical Engineering Materials Science Chemical Engineering Packaging Engineering Pharmaceutical Sciences or a related field

• Deep understanding of biopharmaceutical/pharmaceutical or food packaging design materials sciences and modeling

• Understands Biotechnologys commercialization processes manufacturing process/equipment

• 10 years of business experience leading multifunctional multidisciplinary development organization in the healthcare industry

• Experience with combination products knowledge of applicable guidances regulations and standards

• Proficiency in packaging design and equipment technologies materials and processes

• Strong leadership and team management abilities in a complex regulated industry

• Ability to analyze and optimize operations for improved efficiency and quality rapid problemsolving skills

• Excellent verbal and written communication skills for effective collaboration and reporting

• Proactive approach to identifying and resolving packagingrelated issues

• Ability to handle situational leadership across various intra and inter departmental matters

• Ability to converse technically (mechanically materials modeling regulatory and quality)

• Experienced in leading actionable continuous improvement activities

• Experienced in driving ideation and implementation of environmental sustainability

• Deep understanding of quality management systems tied to clinical manufacturing (production through customer complaints)

• Ability to work in global multifunctional teams in highly matrixed organization lead change and build strong multifunctional skills in your team

• Strong technical writing and interpersonal skills

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.

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.

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