Our Engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
Global Vaccines Technical Operations is seeking a highly motivated individual for the role of Director, Drug Product & Adjuvant Technical Lead. This role will provide technical leadership for the pneumococcal vaccine franchise in the areas of formulation and filling as well as adjuvant manufacturing.
The DP/Adjuvant Technical Lead will provide strategic technical direction through cross-functional partnerships with key stakeholders (e.g. site Technical Operations, External Manufacturing Technical Operations, Sterile Liquids Commercialization, Packaging, Quality, Regulatory-CMC, and the Value Chain Technical Team/Technical Product Council). Specific focus will be placed on ensuring robust manufacturing and analytics, process monitoring, and knowledge management are in place to support franchise goals for safety, compliance, supply, and productivity. The scope includes leading tech transfers for site/image expansion for in-line commercial products, partnering with commercialization for tech transfers of new products, and lifecycle management for existing commercial products/processes.
Responsibilities are as follows:
- Represent Drug Product and adjuvant on the Technical Product Council/Value Chain Technical Team (VCTT), in partnership with internal and external site Technical Operations.
- Partner with Sterile Liquids Commercialization and the IDST Drug Product Working Group to support tech transfers of pipeline products.
- The leadership of tech transfers for in-line commercial products, including expansion to new internal and/or external formulation and filling sites and introduction of new product images.
- The leadership of the drug product and adjuvant lifecycle management, including both issue resolution and risk management as well as optimization and modernization.
- Responsible for a deep understanding of all drug product and adjuvant processes, including oversight of Knowledge Management.
- Maintain expertise in drug product technology future direction, both internally and externally.
- Lead development and implementation of Product/Process Data Management tools, in support of at-site and cross-site monitoring of process performance.
- Partner with the Technical Product Steward and technical leads for other supply chain nodes in the holistic technical oversight and strategy for the franchise.
- Influence, motivate and energize individuals at all levels in the organization.
- Education requirements: Bachelor’s degree in Engineering or Science with 12 years of relevant experience OR Master's degree with 10 years of relevant experience OR Ph.D. with 6 years of relevant experience.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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