Director, Engineering - Clinical and Platform Secondary Packaging
Director, Engineering - Clinical and Platform Secondary Packaging
US - California - Thousand Oaks Apply NowJoin 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.
Director, Engineering - Clinical and Platform Secondary Packaging
What you will do
Let’s do this. Let’s 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 Amgen’s 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
Master's degree and 8 years of leadership in a regulated industry and/or engineering/materials science relevant experience
Or
Bachelor's 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 Biotechnology’s commercialization processes, manufacturing process/equipment
10+ years of business experience leading multi-functional multidisciplinary development organization in the healthcare industry
Experience with combination products, knowledge of applicable guidance’s, 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 problem-solving skills
Excellent verbal and written communication skills for effective collaboration and reporting
Proactive approach to identifying and resolving packaging-related 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 multi-functional teams in highly matrixed organization, lead change, and build strong multi-functional 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 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.
careers.amgen.com
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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.
