Exec. Dir. Process Development (Packaging Engineering and Labeling) – Amgen – Thousand Oaks, CA, USA
The Executive Director Process Development (Packaging Engineering and Labeling) will report to the Vice President Device Technology and will be located in Thousand Oaks, California.
The successful candidate for this position will lead a team of scientists and engineers responsible for the clinical and commercial drug product package and label design and development, package technology and assembly process development, artwork creation for the Americas and Asia/Pacific regions and managing the alignment of all global labeling processes for Amgen’s combination and device products. The candidate will create and implement the long-term strategy to ensure that Amgen becomes and remains an industry leader in this area. They will work cross functionally within PD and across Amgen to create products that create a successful patient experience.
The Executive Director is expected to develop annual goals and strategic direction for the organization that delivers advances in value, speed, efficiency. Have the ability to identify and drive value added technical advances in techniques, concepts, and equipment to advance quality, efficiency and utility of the commercialization process, the lifecycle of products and the overall manufacturing capability of Amgen operations across the global networks. As a key contributor to Amgen’s commercialization process, the Executive Director must maintain strong partnerships with Research and Development, Quality, Sales and Marketing, Customer Experience and with Clinical and Commercial manufacturing sites to positively influence Amgen practices and strategies to ensure success through the commercialization lifecycle.
The Executive Director will be expected to:
- Creates an overall packaging and labeling strategy that ensures Amgen becomes and remains and industry leader in this field
- Consistently deliver results aligned with departmental and program goals
- Drive continuous improvement in the packaging and labeling processes from project initiation through launch, and in alignment with regulatory and commercial manufacturing requirements.
- Provide an environment that enables innovative product technologies and development solutions to further business objectives
- Develop and maintain a high performing team of managers, scientists and engineers with advanced degrees and experience in packaging, labeling and human factors engineering that are professionally and technically competent
- Be a role model in living the Amgen values and leadership attributes
- Identify resource requirements to deliver on program portfolio and negotiate resource assignments from functional leaders
- Deliver progress reports and presentations and ensures that management is aware of the current status, progress and future needs within Operations.
- Facilitate cross-functional senior management discussions on drug delivery business requirements, activities and strategies
- Identify and ensure area of responsibility complies with the most current standards and company policies
- Manage departmental budget, resource planning and staff training
- Maintain a strong grasp of industry trends, leading technology, and market changes with respect to competitive products
- Ensure sound engineering practices are understood and f llowed within department
- Provide leadership and guidance to ensure consultants, contract manufacturers and external business partners comply with business standards and requirements
- Lead industrial efforts that drive industry standards and influence regulatory bodies.
- Developing a product and getting it to the shelf on time is important, but not sufficient. To be successful in this role, you must understand the post-market outcomes with the product.
Basic Qualifications
- Doctorate degree & 6 years of Product Strategy Operations experience OR
- Master’s degree & 10 years of Product Strategy Operations experience OR
- Bachelor’s degree & 12 years of Product Strategy Operations experience AND
- 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
- Advanced Degree in Life Sciences and Engineering
- 12 or more years of experience in the biotechnology/ pharmaceutical industry including leadership assignments in key Operations functions (Process Development, Manufacturing or Quality) with a distinguished track record of delivering results
- Pharmaceutical product commercialization and life cycle management experience; ability to recognize strategic implications of complex product development activities and manage them cross-functionally
- Project Management experience, including the ability to identify and execute strategic initiatives, manage multiple projects, prioritize project resources, and assess project effectiveness and efficiency
- Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and influence decision-making
- Ability to communicate vertically and horizontally through multiple channels, leverage contact network to motivate diverse teams, and enable cross-functional collaboration
- Comfort with complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analyses and facilitate decision-making
- Ability and aptitude to manage timelines and deliverables, to recognize issues and potential impacts, and to take actions rapidly and proactively
- To be successful in this role, you must understand the post-market outcomes with the product
- Demonstrated leadership of highly technical experts with demonstrated results across the new drug product development process and life cycle management.
- Knowledge of, and hands-on experience with bringing new biotech products to market, across various dosage forms and device delivery systems.
- Understanding of primary containers (syringes, cartridges, and vals), labeling and packaging, cold chain expertise
COMPETENCE MODEL DIMENSIONS
- Process, Technical & Network Knowledge
o Well versed in fundamentals of packaging and labeling
o Sound knowledge of CMC Excellence and Commercialization processes
- Partnerships
o Strong knowledge of partnership framework and considerations
- Knowledge of Regulatory Requirements
o Effective understanding of regulatory requirements, trends and implications to program / Amgen
- Financial/Business Acumen
o Ability to use financial tools to balance top-line and bottom-line considerations
o Operates with strong grasp of Amgen’s critical business aspirations and implications
- Operates at Appropriate Altitudes
o Knows when and how to escalate to the appropriate level to drive decisions
o Balances resources and level of engagement based on risk and value
o Establishes credibility by driving to the appropriate level of detail when necessary
o Engages the audience with the right content
o Understands how product can contribute to Operations/Amgen imperatives
o Thrives in leading through complex and ambiguous situations
o Demonstrates accountability across programs and functions
- Executive Presence
o Demonstrates leadership quality, poise, flexibility & adaptability at all levels
o Conveys confidence: demonstrates command in depth of program material and thoughtfulness of program strategies
o Exhibits superb written and verbal communication skills
- Cross-Functional Influence
o Serves as thought leader for critical program strategies & decisions
o Serves as a critical change agent in shaping Amgen’s future
o Challenges & champions decisions through purposeful engagement of critical partners
o Builds strong, broad set of relationships as foundation to support influence
- Judgment
o Knows the right things to say at the right times
o Displays keen judgment on who, how and what requires influence
o Exhibits purposeful assertiveness targeted at an improved outcome
o Translates opportunities and challenges into meaningful actions for Amgen
