Global Vaccines Technical Operations is seeking a highly motivated individual for the role of Director, Technical Product Steward and Polysaccharide Technical Lead. This role will provide technical leadership for the pneumococcal vaccine franchise in the areas of end-to-end technical product stewardship and multi-node polysaccharide manufacturing technical leadership.
The Technical Product Steward/Technical Lead will provide strategic technical direction through cross-functional partnerships with key stakeholders (e.g. site Technical Operations, Vaccine Process Development & Commercialization, Quality, Regulatory-CMC, and the Value Chain Management Team/Integrated Development & Supply Team). 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 supporting tech transfers 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:
Collaborate with research, process development, and manufacturing sites to support New Product Introductions, enabling on-time, right-first-time vaccine technology transfers.
Serve as the single point of technical governance to the Value Chain Management Team (VCMT) through the leadership of the cross-functional Technical Product Council (TPC) to manage all technical aspects of product lifecycle management (issue resolution and continuous improvement).
Responsible for the identification, justification, prioritization and facilitation of technical strategic projects. Responsible for technical aspects of all process unit operations and upgrades.
Lead above-site projects through all phases: project planning, project management and execution.
Provide support for strategic initiatives: technical reports, data analysis, process monitoring, site comparisons and technical risk assessment.
Build and maintain strong and trusting relationships with site leaders, functional management, and other stakeholders to ensure effective communication of plans and issues.
Communicate strategic plans and align team towards a shared vision/mission with a focus on delivering tangible results. Influence, motivate, and energize individuals at all levels in the organization.
Provide leadership and mentoring of direct reports and colleagues to ensure consistent, high quality, technical output.
Responsible for deep understanding of all pneumococcal polysaccharide manufacturing, including oversight of Knowledge Management.
Lead development and implementation of Product/Process Data Management tools, in support of at-site and cross-site monitoring of process performance.
Education Minimum Requirement:
Demonstrated problem solving, effective verbal and written communication, and cross-functional team influencing and leadership skills.
Ability to collaborate effectively, across functional boundaries, to align stakeholders and sponsors on technical strategies.
Proficiency with pharmaceutical industry technical business processes: change control, deviation management, technical protocols/reports, and BLA/MAA regulatory license documents.
Master's Degree or Ph.D. Degree
Demonstrated experience in pneumococcal vaccine Drug Substance and/or Drug Product manufacturing.
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.
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.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at email@example.com
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Merck & Co., Inc.