Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
A Product Steward Director, Operations is the designated expert in one or more subject areas of vaccine/large molecule process science and will provide end-to-end support of manufacturing science and technology for both commercial products and pipeline vaccines with a global scope. Areas of vaccine/large molecule process science include and not limited to bacteriology, virology, cell culture, protein chemistry/folding, reaction chemistry for biologics, upstream processing, downstream processing/separations. The position resides within a Technical Operations Center of Excellence and supports all existing and new vaccine manufacturing operations within our Manufacturing Division. This Product Steward is expected to serve as a leading scientific expert for their designated species, providing guidance, recommendations and judgment for strategic technical issues and decisions.
Ensure and quantify process robustness metrics of all existing and new production processes leading to the highest batch success rate possible
Collaborate with research, process development, and internal/external 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 Research & Development, Supply Chain Management and Marketing through the leadership of the cross-functional Technical Product governance to manage all technical aspects of product lifecycle management (issue resolution and continuous improvement)
Build and maintain strong and trusting relationships with R&D Species Leaders, Value Chain Leaders, site leaders, functional management, and other stakeholders to ensure effective communication of plans and issues
Stay abreast of scientific developments and trends in their designated subject area and participate in external industry/regulatory forums in order to maintain an industry-leading level of subject proficiency
Provide technical/scientific guidance and oversight to project teams that are doing process changes, process improvements or technology transfers to ensure scientific rigor
Provide technical/scientific guidance to major investigations related to their area of expertise, for example, investigations related to yield declines or stability trends
Establish company “best practices” and standards where appropriate as relate to their area of expertise
Develop recommendations and options for process improvements
Education Minimum Requirements
At least a Bachelor's degree in a technical or scientific discipline such as Biology, Chemistry or Chemical Engineering
Preferred: PhD or advanced degree with specialization in a subject pertinent to vaccine/large molecule manufacturing
Required Experience and Skills
At least twelve (12) years of relevant work experience.
Commercial processes for vaccines/large molecules is required, either in development or in technical support
Demonstrated problem solving, effective verbal and written communication
Solid scientific understanding of vaccine and/or biologic products and processes and their effective integration with relevant regulatory (USDA and/or GMP) requirements
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 regulatory license documents
Preferred Experience and Skills
- Prior People Management 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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If you need an accommodation for the application process please email us at firstname.lastname@example.org
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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.
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Flex Time, Remote Work, Telecommuting
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