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Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

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Product Quality Director - Synthetics

Overview

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. 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.

What you will do

Let’s do this. Let’s change the world.

In this vital role you will be the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas on the resolution of issues associated with process/manufacturing, in process controls, analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions and inspections. The PQL has responsibility for driving change to implement operationally efficient processes and corporate alignment across international sites. As a leader in Product Quality, the successful candidate is expected to have experience, knowledge and understanding of small molecule, peptide, and/or oligonucleotide development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Amgen Quality Management Systems.

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 patients.

This role is directly responsible for the product quality and related activities (e.g., comparability, specifications, stability, annual product review) in support of the Product Development Team (PDT). The PQL provides scientific oversight for the product quality of pivotal and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant GMP system, and support for regulatory audits and responses to questions. The individual is directly responsible for leading a Product Quality Team (PQT), including oversight of the product stability programs, providing indirect staff management and guidance to members of the PQT.

Responsibilities

Provide effective, cross-functional quality leadership, and manage multiple, complex long-term PDT deliverables for late phase and commercial 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
Provide expertise in science and risk-based evaluation of complex processes 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 Amgen leadership, peers and regulatory agencies including communications associated with inspectional activities
Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Understand and respond to the impact of emerging scientific/technical trends and their implications for Amgen
Actively mentor new and existing team members to develop Product Quality core skills

Qualifications

Basic Qualifications

Bachelor's Degree and 9 years of Quality, Operations, Scientific, or Manufacturing experience OR
Master's Degree and 7 years of Quality, Operations, Scientific, or Manufacturing experience OR
Doctorate Degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications

Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
Expertise in the areas of drug substance and drug product manufacturing, analytical testing, and industry regulations related to small molecules, peptides and/or oligonucleotides.
8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
6+ years working in a regulated environment (direct GMP)
4 years experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
2+ years experience as a technical expert or product champion
1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation.
1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience in Project Management in support of product development
Knowledge of quality, compliance and regulatory requirements
Knowledge of analytical techniques used for synthetic product quality control
Understanding of drug substance and drug product development and manufacturing
Strong leadership and management skills
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
Previous experience working on a cross-functional team in a matrix environment
Excellent written and verbal communication skills, including facilitation and presentation skills

Benefits

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.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

Sponsorship for this role is not guaranteed.

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.

#J-18808-Ljbffr","

Product Quality Director - Synthetics

Overview

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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. 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.

Product Quality Director – Synthetics

What You Will Do

Let’s do this. Let’s change the world.

In this vital role you will be the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas on the resolution of issues associated with process/manufacturing, in‑process controls, analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions and inspections. The PQL has responsibility for driving change to implement operationally efficient processes and corporate alignment across international sites. As a leader in Product Quality, the successful candidate is expected to have experience, knowledge and understanding of small molecule, peptide, and/or oligonucleotide development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Amgen Quality Management Systems.

Provide effective, cross‑functional quality leadership, and manage multiple, complex long‑term PDT deliverables for late phase and commercial 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
Provide expertise in science and risk-based evaluation of complex processes 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 Amgen leadership, peers and regulatory agencies including communications associated with inspectional activities
Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Understand and respond to the impact of emerging scientific/technical trends and their implications for Amgen
Actively mentor new and existing team members to develop Product Quality core skills

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 self‑starter with these qualifications.

Basic Qualifications

Bachelor’s Degree and 9 years of Quality, Operations, Scientific, or Manufacturing experience
Master’s Degree and 7 years of Quality, Operations, Scientific, or Manufacturing experience
Doctorate Degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications

Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
Expertise in the areas of drug substance and drug product manufacturing, analytical testing, and industry regulations related to small molecules, peptides and/or oligonucleotides.
8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
6+ years working in a regulated environment (direct GMP)
4 years experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
2+ years experience as a technical expert or product champion
1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation.
1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience in Project Management in support of product development
Knowledge of quality, compliance and regulatory requirements
Knowledge of analytical techniques used for synthetic product quality control
Understanding of drug substance and drug product development and manufacturing
Strong leadership and management skills
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
Previous experience working on a cross‑functional team in a matrix environment
Excellent written and verbal communication skills, including facilitation and presentation 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

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.

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.

Seniority level

Not Applicable

Employment type

Full-time

Job function

General Business, Strategy/Planning, and Product Management
Biotechnology Research and Pharmaceutical Manufacturing

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5 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

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