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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.
Technical Specifications Manager – Raw Materials
Let’s do this. Let’s change the world. In this vital role you will be responsible for the development, implementation, maintenance, and lifecycle management of clinical and commercial raw material specifications and related controlled documents. This role ensures specifications are scientifically accurate, compliant with regulatory and pharmacopeial requirements, and aligned with manufacturing processes and quality standards. The Technical Specifications Manager works closely with Process Development, Material Sciences, Engineering, Quality Assurance, Quality Control, Supply Chain, Regulatory Affairs, and external suppliers to translate technical and manufacturing requirements into clear, compliant, and effective raw material specifications. The role also identifies and drives continuous improvement initiatives to enhance specification quality, standardization, efficiency, and compliance across the specification lifecycle.
Author, revise, and maintain clinical and commercial raw material specifications and related controlled documents.
Ensure specifications are scientifically accurate, compliant with cGMP, pharmacopeial (USP, EP, JP), and internal quality requirements.
Translate technical, manufacturing, and regulatory requirements into clear and effective raw material specifications.
Manage specification lifecycle activities, including new material introductions, revisions, periodic reviews, supplier changes, obsolescence, and implementation of approved changes.
Partner with Process Development, Material Sciences, Engineering, Quality Assurance, Quality Control, Supply Chain, Regulatory Affairs, Manufacturing, and external suppliers to develop and maintain raw material specifications.
Facilitate specification review meetings, drive resolution of technical issues, and ensure timely completion of action items.
Support material qualification, technology transfers, investigations, supplier onboarding, and regulatory inspections as the specification subject matter expert.
Identify and implement opportunities to improve specification quality, consistency, efficiency, and compliance.
Support standardization of specification templates, authoring practices, and lifecycle processes.
Contribute to digital transformation and process improvement initiatives that enhance specification management and data quality.
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
OR
Master’s degree and 2 years of relative experience
OR
Bachelor’s degree and 4 years of relative experience
OR
Associate’s degree and 8 years of relative experience
OR
High school diploma / GED and 10 years of relative experience
Preferred Qualifications:
Bachelor’s or master’s degree in chemistry, biology, or related subject
Experience with raw materials specifications
Familiarity with PLM software (product lifecycle management)
Quality experience is a plus
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:
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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
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A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
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Stock-based long-term incentives
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Award-winning time-off plans
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Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
careers.amgen.com
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 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.
