You are the designated expert in one or more subject areas of vaccine/large molecule bioprocess science and will provide end-to-end support of manufacturing science and technology for both commercial products and pipeline vaccines with a global scope.
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. We 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.
For our location in Boxmeer we are looking for a:
BTS PRODUCT STEWARD SWINE (P5)
In this new position you are responsible for (further) developing production processes related to our Swine vaccine portfolio. 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 the Swine portfolio, providing guidance, recommendations and judgment for strategic technical issues and decisions. Responsibilities are (but are not limited to):
- 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 Swine 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
This position reports works closely with a variety of internal (a.o. R&D, Marketing, Sales, Registration, Manufacturing, QA, QC) and external (a.o. Universities, (Research) Institutes, Governmetal Institutes) stakeholders. You report to the Product & Platform Steward Lead.
- Bachelor of Science or equivalent 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 is highly preferred
- Experience with commercial processes for vaccines/large molecules 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 BLA/MAA regulatory license documents
- Excellent command of the English language
- Living at a reasonable distance of Boxmeer
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. We offer you competitive and matching conditions.
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.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Keywords: Research, PhD, Biomedisch, Chemisch, Chemical Engineering, Boxmeer, Noord-Brabant.