Merck
Technical Lead, Lyophilization/ Fill-Finish
Join our Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) team as a leading scientific Commercial Lyophilization (Freeze Drying) expert! The Technical Lead, Lyophilization/ Fill-Finish will provide guidance, recommendations, and judgment for strategic technical issues and decisions pertaining to the following domains
commercial freeze drying (lyophilization) and fill-finish. The Technical Lead will ensure a robust first principles-based tech-transfer and scale-up of lyophilization while working cross functionally with our Animal Health Large Molecule strategy team, regional operations team, and engineering teams involved in capital investment, technology transfer, and operational readiness to ensure scientific rigor. Responsibilities: Build and maintain strong and trusting relationships with our Manufacturing Division and Global Engineering leadership, and other stakeholders to ensure effective communication for scoping, planning, and change management. Stay abreast of scientific developments and trends in fill-finish domain and participate in external industry/regulatory forums to maintain an industry-leading level of subject proficiency resulting in continuous improvement culture. Support scoping, planning of network manufacturing operations at a strategic level within our company's Animal Health division. Serve as a leading scientific expert providing strategic guidance, recommendations, and judgment for technical issues and decisions pertaining to freeze drying equipment, technology-transfer of inline cycles, and broader aseptic fill-finish technology with regards to Global Animal Health Manufacturing (GAHM) strategy. This position will not have employee management responsibilities. Minimum Qualifications: Education: Bachelor of Science or equivalent 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 manufacture Skills: At least seven years of relevant work experience in the vaccines, pharmaceutical, biotech, or related field. Experience in analysis of commercial lyophilization processes for vaccines/large molecules/small molecules, either in development, operational, or in technical support role. Strong scientific understanding of Animal Health vaccine and/or biologic products and processes and their effective integration with relevant regulatory/GMP requirements. Preferred: Ability to collaborate effectively, across functional boundaries, to align stakeholders and sponsors on technical strategies. Demonstrated problem solving, effective verbal and written communication, and people management skills. Proficiency with pharmaceutical industry technical business processes: change control, deviation management, technical protocols/reports, and regulatory license documents.
Join our Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) team as a leading scientific Commercial Lyophilization (Freeze Drying) expert! The Technical Lead, Lyophilization/ Fill-Finish will provide guidance, recommendations, and judgment for strategic technical issues and decisions pertaining to the following domains
commercial freeze drying (lyophilization) and fill-finish. The Technical Lead will ensure a robust first principles-based tech-transfer and scale-up of lyophilization while working cross functionally with our Animal Health Large Molecule strategy team, regional operations team, and engineering teams involved in capital investment, technology transfer, and operational readiness to ensure scientific rigor. Responsibilities: Build and maintain strong and trusting relationships with our Manufacturing Division and Global Engineering leadership, and other stakeholders to ensure effective communication for scoping, planning, and change management. Stay abreast of scientific developments and trends in fill-finish domain and participate in external industry/regulatory forums to maintain an industry-leading level of subject proficiency resulting in continuous improvement culture. Support scoping, planning of network manufacturing operations at a strategic level within our company's Animal Health division. Serve as a leading scientific expert providing strategic guidance, recommendations, and judgment for technical issues and decisions pertaining to freeze drying equipment, technology-transfer of inline cycles, and broader aseptic fill-finish technology with regards to Global Animal Health Manufacturing (GAHM) strategy. This position will not have employee management responsibilities. Minimum Qualifications: Education: Bachelor of Science or equivalent 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 manufacture Skills: At least seven years of relevant work experience in the vaccines, pharmaceutical, biotech, or related field. Experience in analysis of commercial lyophilization processes for vaccines/large molecules/small molecules, either in development, operational, or in technical support role. Strong scientific understanding of Animal Health vaccine and/or biologic products and processes and their effective integration with relevant regulatory/GMP requirements. Preferred: Ability to collaborate effectively, across functional boundaries, to align stakeholders and sponsors on technical strategies. Demonstrated problem solving, effective verbal and written communication, and people management skills. Proficiency with pharmaceutical industry technical business processes: change control, deviation management, technical protocols/reports, and regulatory license documents.