Principal Product Quality Leader (Synthetics)

Regulatory Jobs; Thousand Oaks (CA); On-site; USD 139,000 - 188,000; Full time

Job summary

Amgen in Thousand Oaks, CA, seeks a Principal Product Quality Leader (Synthetics) to provide technical leadership within Product Quality for late-phase and commercial synthetic programs. You will work across Product Quality, International Quality, Quality Control, Regulatory, Process Development, QA and other departments on projects, investigations, and regulatory submissions.

The role interfaces between research, development, and manufacturing to ensure medicines meet quality and regulatory

Qualifications

• Doctorate or higher with 2+ years in Quality, Operations, Scientific or Manufacturing
• Master’s with 4+ years in Quality, Operations, Scientific or Manufacturing
• Bachelor’s with 6+ years in Quality, Operations, Scientific or Manufacturing

Responsibilities

• Provide cross-functional quality leadership for late phase and commercial synthetic programs, including PQT, APR, specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs
• Support science and risk-based evaluation of complex process and product quality data, developing patient-oriented strategies
• Demonstrate proficiency in oral and written communication to Product Quality leadership, peers and regulatory agencies
• Demonstrate knowledge of cGMP and international regulatory expectations

Job description

Career Category

Quality

Job Description

Join 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. 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.

Principal Product Quality Leader (Synthetics)

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide technical expertise and product leadership to the Product Quality organization. As a product expert in Quality, the Principal Product Quality Leader has responsibility for working with Product Quality Leaders, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on projects, issue resolution, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.

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 we’re 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.

This role will support one or more of Amgen's synthetic products. The individual will provide technical expertise and project support to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the Product Development Team goals. The individual will be directly responsible for Product Quality related tasks including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (change control, data systems, etc), and product data management, including comparability assessments, annual product reviews, and product quality risk assessments. In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health. This role is preferred to be on site at one our Amgen locations, remote will be considered if applicable.

Key Responsibilities include:

• Provide effective, cross-functional quality leadership, and support PDT deliverables for late phase and commercial synthetic programs, including actions required for the PQT, APR, specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and 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
• 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

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
• Master’s degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Bachelor’s 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 advance 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)
• 1+ year experience with authoring or review of market applications, IND, supplements or similar regulatory documentation
• 1+ year experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
• Experience in Project Management in support of pharmaceutical development
• Understanding of synthetic pharmaceutical bulk and drug product development, manufacturing, and analytical techniques
• General knowledge of cGMP and US & international filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals and/or biopharmaceuticals
• Experience working on a cross-functional team in a matrix environment
• Excellent written and verbal communication skills, including facilitation and presentation skills
• A strong foundation in chemistry and experience with new synthetic modalities/ technologies such as peptides, siRNA, new extended release formulations, and or combination products is a plus

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 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 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.

Salary Range

138,639.25USD -187,570.75USD