Product Quality Director

Initial Therapeutics, Inc.; Washington (District of Columbia); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision benefits

Stock-based incentives

Flexible work models

Time off

Job summary

Amgen seeks a Product Quality Director to lead the Product Quality Team, providing expert scientific oversight, strategic leadership, and cross-functional collaboration across PQ, Regulatory, and manufacturing groups. The role emphasizes lifecycle management for large molecule products, risk assessment, and regulatory readiness.

The successful candidate will mentor staff, drive compliant quality systems, and partner with executive leadership to advance development and commercial products while

Qualifications

• Doctorate degree and 4 years of Quality/Operations/Scientific/Manufacturing experience, OR
• Masters degree and 7 years of Quality/Operations/Scientific/Manufacturing experience, OR
• Bachelor's degree and 9 years of Quality/Operations/Scientific/Manufacturing experience
• Advanced degree in chemistry, biochemistry, biology, or related biotechnology sciences
• Expertise in protein and small molecule analysis and industry regulations
• 8+ years of pharmaceutical experience with increasing responsibility in quality/analytical development/process development/pharmaceutics/regulatory/manufacturing
• 6+ years working in a regulated environment (GMP)
• 5+ years managing staff with increasing responsibilities and larger groups
• 2+ years experience as a PQL/technical professional
• 1+ years of experience with regulatory filing documentation
• 1+ years supporting non-conformance investigations
• Experience in Project Management for product development
• Knowledge of protein and small molecule quality and regulatory requirements
• Knowledge of analytical techniques for protein product quality control
• Understanding of drug substance/product development and manufacturing
• Strong leadership and management skills
• General knowledge of cGMP and filing regulations

Responsibilities

• Provide effective cross-functional quality leadership for late phase and commercial programs.
• Develop patient-oriented strategies accounting for business needs and complex issues.
• Communicate complex information to Amgen leadership and regulatory agencies.
• Maintain knowledge of cGMP and international regulatory expectations.
• Anticipate scientific/technical trends and their implications for Amgen.
• Mentor new and existing team members to develop Product Quality skills.

Skills

Quality leadership

Product Quality

Regulatory filings

cGMP knowledge

Stakeholder communication

Education

Doctorate degree

Master's degree

Bachelor's degree

Advanced degree in chemistry/biochemistry/biology

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. 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, 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.

Product Quality Director

What you will do

Lets do this. Lets 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, comparability, stability, reference standards, importation testing, investigations, change control, regulatory submissions and inspections. The PQL has responsibility for inspiring 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 large molecule development and commercial lifecycle maintenance, product stability programs, 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 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.

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 (EDMQ, change control, etc), and support for regulatory audits and responses to questions. The individual is directly responsible to lead a Product Quality Team (PQT), including oversight of the product stability programs, and providing indirect staff management and guidance to members of the PQT.

Key Responsibilities include:

• 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 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 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 dynamic professional we seek is a collaborate leader with these qualifications

Basic Qualifications:

• Doctorate degree and 4 years of Quality, Operations, Scientific or Manufacturing experience OR

• Masters degree and 7 years of Quality, Operations, Scientific or Manufacturing experience OR

• Bachelors degree and 9 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 protein and small molecule analysis and industry regulations

• 8+ years of pharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience

• 6+ years working in a regulated environment (direct GMP)

• 5+ years managing staff with increasing responsibilities and larger groups

• 2+ years experience as a PQL, technical professional 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 protein and small molecule quality, compliance and regulatory requirements

• Knowledge of analytical techniques used for protein molecule 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, 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.

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.