Director of Packaging Commercialization, Solids and Specialty – Merck – West Point, PA
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Packaging has become an integral part of the future success of Merck and delivering value to customers. From enabling patient medication adherence, to providing differentiation, product protection, local access, and serving the gamut of high value-low volume products through delivering manufacturing’s highest quality, lowest cost, shortest lead time goals. Packaging is not only a key capability for the future but Merck’s capabilities technical, organizational and managerial are transforming rapidly and vitally. We need a leader to join in this exciting transformation.
The Director of Packaging Commercialization, Solids and Specialty is responsible for the leadership of all packaging development, filing and sustained launch of all human health solid oral dosage and specialty (polymeric inserts, inhalation, intranasal, non-sterile creams, ointments etc.). The position is responsible for leading a group of new products packaging engineers who support activities for this portfolio including:
Packaging Selection with integrated Product/Operational Characterization (moisture, light, thermal, mechanical etc. sensitivities)
Primary Packaging Development
Input to Clinical/Non-Commercial Packaging Development
Secondary Packaging Development (including PDPB-Product Definition Part B process)
Formal Stability Studies Packaging Planning & Execution
Filing Preparation for Packaging Sections
Bulk Packaging Development (including end-to-end PDPC-Product Definition Part C process)
Tertiary/Distribution & Logistics Packaging Development (Cold Chain design as needed)
Packaging Site Readiness (Internal or External)
Post-Launch Support for some period post-launch and transition to Site Technical Operations
Other requirements: Customer-focused design, Child Resistance, Human Factors, Design for Environment, Security etc.
This Director will direct and guide the new products packaging engineers under him/her to utilize advanced knowledge and skills to optimize business, technical, and compliance processes. He/she will accountable for all approvals (either directly or through delegation) of documentation for solids and specialty packaging development.
As an organizational and functional leader, the Director will build talent through direct coaching and mentoring of his/her direct reports through programs and actions as well as working with them to create meaningful and actionable EDPs that enhance strengths and work on opportunities. He/she will utilize and advance the High Performance Packaging Development (HPPD) framework to manage the portfolio of activities as well as lead and manage the group through programmatic and continuous improvement projects.
The person in this position creates and participates in high impact, complex, cross-functional forums, and will provide significant leadership to achieve new product goals. This will often require building cross-functional and boundary-less interfaces or decision making forums that involve a variety of functional areas including but not limited to:
Formulation development, Analytical development, Marketing (Global Human Health), Procurement, Artwork, Labeling, Supply Chain Mgmt. including Global Logistics, Site Packaging Operations (internal and ExM as appropriate), Packaging Tech Ops as needed (equipment, documentation, logistics technology), Device Development, Global Reg Affairs, Quality and Analytical, Global Security, Branding, Legal, API/bulk development etc.
The Director will also support the understanding of activities/efforts to drive packaging positions and strategy on new/changing requirements and contribute to the strategic changes in MMD’s World Class Supply and Industry Leader in New Product Launch initiatives. He/she will work most closely with the Small Molecule Line of Business (LOB) to ensure that the needs of customer value, highest quality, lowest cost and shortest lead times are being accomplished in the packaging, distribution, use and disposal of new products. He/she will thus be a major contributor to Merck/MSD’s customer centricity, adherence, global security, environmental, pediatric, healthy aging, late stage customization, 90 day and logistics strategies among others.
Bachelors degree (Science or Technical) or higher required. Preferred Chemical Engineering, Mechanical Engineering, Packaging Sciences/Engineering or similar.
Bachelor’s with 7+ years of experience or Master’s with 5 years of experience.
Demonstration of Merck Leadership Behaviors.
Excellent written skills – ability to communicate complex ideas and concepts in clear and elegant ways.
Experience with cGMPs, Pharmaceutical industry regulations, and project management.
Experience with operations, materials, and manufacturing processes.
New product introduction and commercialization experience.
Knowledge of IDST (Integrated Development and Supply Teams)
Experience in leading and facilitating diverse teams.
Experience and interest in growing talent and coaching individuals from various backgrounds, skills levels and strengths.
Ensuring all activities are conducted with the highest regard for all Merck divisional and local site procedures for safety, quality, regulatory and all other compliance.
Experience in providing technical and managerial leadership to activities, including approval and preparation of technical documents.
Provide technical and managerial leadership to packaging sites particularly for new product introductions.
Experience with FDA and other regulatory agency needs and requirements.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Visa sponsorship is not available for this position.
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NA-US-NJ-Whitehouse Station West, NA-US-NJ-Kenilworth, NA-US-NJ-Rahway
Yes, 25 % of the Time
Number of Openings
Shift (if applicable)