Product Quality Director - Synthetics

Amgen • Cambridge, MA

7d

About The Position

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. 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 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.

Requirements

• 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

Nice To Haves

• 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

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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees