Senior Manager - Stability

• The Stability function is part of the Amgen Product Quality organization, providing governance and management of lean, harmonized, and compliant Stability data packages for all of Amgens products.
• In this team-based role, the Senior Manager Stability will collaborate with Product Quality Teams (PQTs) and the supporting Specialists to ensure the design, management, maintenance, and data analysis of a products stability program support GMP compliance and meet the Market Authorization commitments. In this leadership and management role you will provide critical support to PQTs through management of activities and staff supporting stability programs for late-stage clinical and commercial products to ensure PQT deliverables and requirements are met.
• In this team-oriented leadership role, you will serve as a subject matter expert of commercial product stability and GMP data management strategy, directly adding to the success of PQTs by ensuring support for the commercial product stability programs, collaborating on issue resolutions and investigations, and working closely with diverse functional groups including Supply Chain, Manufacturing, Global CMC Statistics, External Supplier Quality, Quality Control, Regulatory, Quality Assurance, external providers, and other departments on a variety of activities. Such activities include annual stability lot selection and testing support, annual product review data preparation & assessment, and, where warranted, investigations, regulatory submissions and support for inspections across the Amgen manufacturing and testing network.
• The Senior Manager will oversee the stability strategy and studies within quality systems (e.g. SampleManager LIMS), provide guidance for stability lot selection and study initiation to support the on-going stability commitments, manage product quality/stability data in various GMP applications, manage and oversee annual product reviews and regulatory filing updates, and support GMP inspections.
• This role requires strong expertise in GMP compliance, staff management, time management, stability strategy compliance with ICH and other international regulations and guidance, and cross-functional collaboration. Successful navigation skills for matrixed team environments are essential.
• You will also contribute to business process improvements by contributing towards improvements to procedures and work instructions, as well as the development of electronic data management tools such as Spotfire and SHINY applications.

• Provide oversight of the lifecycle management for commercial product stability programs
• Ensure the execution of a products on-going (annual) stability program is supported by a team of subject matter experts
• Review GMP stability data for commercial products
• Provide support for product stability transactions and data reports in relevant GMP computer-based systems (Document Management System, SampleManager LIMS, Regulatory Information Management System, etc.)
• Assist with escalation of unexpected data trends and/or out-of-specification results to Product Quality Teams, applying keen attention to detail
• Assist with procuring stability samples from internal and external manufacturing sites
• Collaborate with Quality test labs (internal and external) to ensure the smooth execution of stability studies in compliance with standard operating procedures
• Oversee the management of multiple time-sensitive activities, particularly those supporting annual product reviews
• Represent Stability function on cross-functional meetings and/or investigations

Basic Qualifications & Experience:

• Doctorate degree & 8 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Masters degree & 12 years of Quality, Operations, Scientific, or Manufacturing experience OR
• Bachelors degree & 15 years of Quality, Operations, Scientific, and/or Manufacturing experience

Functional Skills:

Must-Have Skills:

• Proven experience leading cross-functional teams in a matrix environment
• Demonstrated proficiency in oral and written communication of complex information to leadership, peers and regulatory agencies
• Demonstrated proficiency in knowledge of cGMP and international regulatory expectationspertaining to the stability testing of pharmaceuticals and bio-pharmaceuticals
• Strong scientific data management and organization skills with attention to detail
• B.S. or advance degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and experience with growing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment
• Proven ability to manage time-sensitive activities across global teams
• Proficiency in MS Office (Word, Excel PowerPoint, Teams, Outlook)

Good-to-Have Skills:

• Expertise in GMP applications (Veeva, Spotfire, LIMS)
• Experience with authoring, assembling, and reviewing annual product reviews
• Expertise in stability life cycle management
• Strong project management and team collaboration skills
• Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques
• Continuous improvement mindset with experience applying lean principles
• Experience collaborating across time zones in a global, matrixed team environment

Soft Skills:

• Proven analytical and problem-solving skills
• Ability to work effectively with global, virtual teams
• Strong team management skills
• Strong presentation and public speaking skills for leadership and cross-team updates
• High degree of initiative and self-motivation
• Ability to manage multiple staff and priorities successfully, react quickly to address urgent requests and meet challenging timelines
• Team-oriented, with a focus on achieving team goals