Associate Director Manufacturing - Platform Steward Replicon Particle (RP) Technology
- New Century, KS
Highly demanding position ensuring and remaining an in-control technology platform and serve as subject matter expert throughout the organization.
The global Bioprocess Technology Solutions (BTS) team drives and executes Bioprocess technology excellence in close alignment with their partners in R&D and Manufacturing in order to ensure robust product introductions, product transfers and a reliable product supply to customers. BTS has considerable expertise in viral cell culture, bacterial fermentation, downstream processing, purification, freeze drying and vaccine formulation. They are responsible for seed development, new product process development, validation/qualification and commercialization of AH's large vaccine pipeline. In addition, the team provides in-line product support for all Animal Health large molecule manufacturing sites and external manufacturers.
In this position you are the designated expert in Replicon Particle (RP) technology 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. You are expected to serve as a leading scientific expert for their designated species, providing guidance, recommendations and judgment for strategic technical issues and decisions.
- Collaborating with research, process development, and internal/external manufacturing sites to support New Product Introductions, enabling on-time, right-first-time vaccine technology transfers
- Serving 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)
- Building and maintaining 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
- Staying 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
- Providing technical/scientific guidance and oversight to project teams that are doing process changes, process improvements or technology transfers to ensure scientific rigor
- Providing technical/scientific guidance to major investigations related to their area of expertise, for example, investigations related to yield declines or stability trends
- Establishing company "best practices" and standards where appropriate as relate to their area of expertise
- Developing recommendations and options for process improvements
This position works closely with a variety of internal (a.o. R&D, Marketing, Sales, Registration, Manufacturing, QA, QC) and external (a.o. Universities, (Research) Institutes, Governmental Institutes) stakeholders. You report to the Product & Platform Steward Lead.
Education Minimum Requirement
- Bachelor's degree in a technical or scientific discipline such as Biology, Chemistry or Chemical Engineering
- PhD or advanced degree with specialization in a subject pertinent to vaccine/large molecule manufacture highly preferred
Required Skills and Experience
- Minimum four years of relevant work experience in the pharmaceutical, biotech, or related industry
- Extensive experience with commercial processes for vaccines/large molecules is required, either in development or in technical support
- Demonstrated problem solving, effective verbal and written communication, and people management skills
- Strong scientific understanding of vaccine and/or biologic products and processes and their effective integration with relevant regulatory/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
- Excellent command of the English language
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 ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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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Flexible Work Arrangements:
Flex Time, Remote Work, Telecommuting
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