Principal Product Quality Leader

BioSpace; Washington (District of Columbia); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Retirement plan

Stock incentives

Flexible work model

Job summary

Amgen is seeking a Principal Product Quality Leader to provide technical leadership within the Product Quality Team, interfacing with International Distribution Quality, Regulatory, and Manufacturing to drive product improvements and investigations. You will own regulatory filings, comparability, stability programs, and quality risk assessments for late-stage and commercial biologics.

The role emphasizes cross-functional collaboration, strong data management, and the ability to navigate global

Qualifications

• Doctorate with 2+ years of Quality, Operations, Scientific, or Manufacturing experience.
• Masters with 4 years of Quality, Operations, Scientific, or Manufacturing experience.
• Bachelors with 6 years of Quality, Operations, Scientific, or Manufacturing experience.
• Associate's degree and 10 years of Quality, Operations, Scientific or Manufacturing experience.
• High School Diploma/GED and 12 years of Quality, Operations, Scientific or Manufacturing experience.

Responsibilities

• Provide cross-functional quality leadership for late phase and commercial programs, including annual product reviews, specifications, comparability and stability programs; site and method transfers; product quality impact assessments; and PQ-owned regulatory filing sections.
• Support science and risk-based evaluation of complex process and product quality data, including developing patient-oriented strategies that account for business needs and/or provide novel solutions.
• Author GMP/Regulatory documents and manage product data as part of the Product Quality Team to meet development goals.

Skills

Communication

cGMP knowledge

Regulatory understanding

Education

Doctorate degree

Master's degree

Bachelor's degree

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 award-winning 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.

Principal Product Quality Leader

What you will do

Lets do this. Lets change the world. Amgens corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader. As Principal Product Quality Leader, you will provide technical expertise and leadership within a Product Quality Team. You will engage with Product Quality, International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities. Such activities include product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.

You will support one or more of Amgen's late-stage or commercial biologics products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals. You will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems and product data management including comparability assessments, annual product reviews, and product quality risk assessments. Your contributions will significantly improve initiatives intended to ensure the overall product health.

Primary Responsibilities Include The Following

• Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs, including actions required for the annual product reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author PQ-owned regulatory filing sections and RTQs
• Support science and risk-based evaluation of complex process and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
• Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies were employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

What we expect of you

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

Basic Qualifications

• Doctorate degree & 2 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Masters degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Bachelors degree & 6 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Associate's degree and 10 years of Quality, Operations, Scientific or Manufacturing experience OR
• High School Diploma/GED and 12 years of Quality, Operations, Scientific or Manufacturing experience

Preferred Qualifications

• B.S. or advanced degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
• 6+ years working in a regulated environment (either direct GMP or technical support) with experience working with biologic products
• 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation

Functional Skills

Must-Have Skills

• Demonstrate proficiency in oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
• Strong scientific data management and organization skills with attention to detail

Soft Skills

• Analytical and problem-solving skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
• Team-oriented, with a focus on achieving team goals

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, 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 sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• 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.

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.

Sponsorship

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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.