Merck
Technical Lead - Lyophilization - Global Animal Health Manufacturing
Merck, Worthington, Minnesota, United States, 56187
Overview
This is a fantastic opportunity to make a substantial impact in establishing new lyophilization manufacturing. As announced earlier in 2025, our Animal Health division is investing $895M to expand manufacturing and R&D in De Soto, Kansas — the 2nd largest economic development project in the state’s history. This new role in Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) will serve as the leading scientific authority for the new commercial lyophilization (freeze‑drying) capacity being built at the site. This role is the Technical Lead for Lyophilization with both deep scientific experience and practical commercial manufacturing judgment. You will lead technical strategy, science‑based technology transfer and scale‑up of freeze‑drying and fill‑finish processes for vaccine and biologic drug products used in Animal Health. This role partners closely with Large Molecule strategy, regional operations, capital engineering, and process development/R&D. Why this role matters
Influence design and scale‑up decisions for freeze‑drying cycles and integrated fill‑finish operations that affect product quality, throughput, and regulatory compliance. Act as the internal and external subject matter steward — translating theory to practice, mentoring teams, and elevating standards across R&D and commercial manufacturing. Drive continuous improvement and risk‑based technical governance at this new lyophilization site. Key Responsibilities
Provide authoritative scientific guidance and technical stewardship across commercialization, tech transfer, and scale‑up of lyophilization and aseptic fill‑finish processes. Lead first‑principles characterization of products and equipment (primary packaging, shelves, vials/stoppers, trays, bulk fill systems) and apply mathematical and heat/mass transfer modeling to design and optimize freeze‑dry cycles and loading strategies. Own the technical aspects of lyophilization tech‑transfer: develop acceptance criteria, comparability strategies, process design space, and CPP rationales for transfer from R&D to commercial lines. Partner with capital engineering and vendors to specify freeze‑drying equipment, auxiliary systems, and automated fill‑finish lines; provide technical input to FAT/SAT protocols, IQ/OQ, PQ, Post‑PQ testing, transfer batches and commercial manufacturing. Collaborate with regional operations and QC/QA to ensure readiness: process validation/qualification planning, batch record design, change control, deviations assessment, and regulatory file support. Translate complex scientific literature into actionable process improvements; represent the company in external industry/regulatory forums, standards bodies, and scientific publications where appropriate. Coach, train, and mentor cross‑functional project teams to build internal capability and promote sound scientific practices. Maintain technical roadmaps, best‑practice libraries, and decision frameworks that balance innovation with animal health quality and regulatory expectations. Who you are (profile)
Recognized, published authority in lyophilization/fill‑finish for biologics or vaccines with a track record of applying science to commercial manufacturing. Experienced at guiding technical decisions across R&D and commercial manufacturing with strong systems thinking and governance discipline. Practical experience with freeze‑dry studies, cycle development and optimization, load configurations, and product characterization (residual moisture, collapse, reconstitution). Comfortable using mathematical modeling and data‑driven approaches (e.g., heat/mass transfer, primary drying kinetics, mathematical models to inform scale‑up and tech transfer decisions). Fluent in quality and regulatory expectations for vaccines/biologics, and pharma technical documentation (protocols, validation reports, change control, deviations, regulatory submissions). Minimum qualifications
Bachelor of Science in Biology, Chemistry, Chemical Engineering, or related technical discipline required. Preferred: PhD or advanced degree with specialization relevant to vaccine/large molecule manufacture (or equivalent technical experience). Experience & skills
Minimum ~7 years’ relevant experience in vaccines, biologics, pharmaceutical, or related industries, spanning R&D, tech transfer, or commercial manufacturing support. Direct hands‑on experience planning and conducting freeze‑dry studies and assessing commercial lyophilization processes. Demonstrated capability in product and equipment characterization, process development, and scale‑up for lyophilization and aseptic fill‑finish. Strong written and verbal communication; proven ability to influence cross‑functional stakeholders and train technical teams. Familiar with change control, deviation management, protocol/report authorship, and regulatory license documentation. Preferred qualifications
Published papers, conference presentations, or recognized contributions in the domain of lyophilization. Experience working across both R&D and commercial manufacturing environments in Animal Health or human biologics. Required Skills
Aseptic Manufacturing, Aseptic Processing, Biologics, Driving Continuous Improvement, Drug Product Development, Fill and Finish, Formulation Optimization, Freeze Dry, Freeze Drying, Good Manufacturing Practices (GMP), Manufacturing, Manufacturing Operations, Manufacturing Scale-Up, Strategic Thinking, Technical Issues, Technical Problem-Solving, Technology Transfer, Vaccine Manufacturing Preferred Skills
Current employees may apply for opportunities within the company. Current contingent workers may apply for opportunities within the company. US and Puerto Rico Residents Only:
Our company is committed to inclusion and providing accommodations during the application or hiring process. If you need an accommodation, please indicate so. Equal Employment Opportunity : We provide equal opportunities to all employees and applicants and prohibit discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights pages. Hybrid Work Model U.S. Hybrid work model: three days on-site per week with Friday remote, with exceptions noted for field-based, facility-based, or remote-designated roles. Specific site requirements may vary. Salary and Benefits The salary range for this role is $126,500.00 - $199,100.00. This range reflects good faith estimates at posting time and depends on education, qualifications, experience, location, and business needs. The successful candidate will be eligible for annual bonus and long‑term incentives, if applicable. We offer a comprehensive benefits package. Application You can apply for this role at the company careers site. The application deadline is noted on the posting. End of Posting This job posting is effective until the listed end date or until it is closed; apply by the stated deadline.
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This is a fantastic opportunity to make a substantial impact in establishing new lyophilization manufacturing. As announced earlier in 2025, our Animal Health division is investing $895M to expand manufacturing and R&D in De Soto, Kansas — the 2nd largest economic development project in the state’s history. This new role in Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) will serve as the leading scientific authority for the new commercial lyophilization (freeze‑drying) capacity being built at the site. This role is the Technical Lead for Lyophilization with both deep scientific experience and practical commercial manufacturing judgment. You will lead technical strategy, science‑based technology transfer and scale‑up of freeze‑drying and fill‑finish processes for vaccine and biologic drug products used in Animal Health. This role partners closely with Large Molecule strategy, regional operations, capital engineering, and process development/R&D. Why this role matters
Influence design and scale‑up decisions for freeze‑drying cycles and integrated fill‑finish operations that affect product quality, throughput, and regulatory compliance. Act as the internal and external subject matter steward — translating theory to practice, mentoring teams, and elevating standards across R&D and commercial manufacturing. Drive continuous improvement and risk‑based technical governance at this new lyophilization site. Key Responsibilities
Provide authoritative scientific guidance and technical stewardship across commercialization, tech transfer, and scale‑up of lyophilization and aseptic fill‑finish processes. Lead first‑principles characterization of products and equipment (primary packaging, shelves, vials/stoppers, trays, bulk fill systems) and apply mathematical and heat/mass transfer modeling to design and optimize freeze‑dry cycles and loading strategies. Own the technical aspects of lyophilization tech‑transfer: develop acceptance criteria, comparability strategies, process design space, and CPP rationales for transfer from R&D to commercial lines. Partner with capital engineering and vendors to specify freeze‑drying equipment, auxiliary systems, and automated fill‑finish lines; provide technical input to FAT/SAT protocols, IQ/OQ, PQ, Post‑PQ testing, transfer batches and commercial manufacturing. Collaborate with regional operations and QC/QA to ensure readiness: process validation/qualification planning, batch record design, change control, deviations assessment, and regulatory file support. Translate complex scientific literature into actionable process improvements; represent the company in external industry/regulatory forums, standards bodies, and scientific publications where appropriate. Coach, train, and mentor cross‑functional project teams to build internal capability and promote sound scientific practices. Maintain technical roadmaps, best‑practice libraries, and decision frameworks that balance innovation with animal health quality and regulatory expectations. Who you are (profile)
Recognized, published authority in lyophilization/fill‑finish for biologics or vaccines with a track record of applying science to commercial manufacturing. Experienced at guiding technical decisions across R&D and commercial manufacturing with strong systems thinking and governance discipline. Practical experience with freeze‑dry studies, cycle development and optimization, load configurations, and product characterization (residual moisture, collapse, reconstitution). Comfortable using mathematical modeling and data‑driven approaches (e.g., heat/mass transfer, primary drying kinetics, mathematical models to inform scale‑up and tech transfer decisions). Fluent in quality and regulatory expectations for vaccines/biologics, and pharma technical documentation (protocols, validation reports, change control, deviations, regulatory submissions). Minimum qualifications
Bachelor of Science in Biology, Chemistry, Chemical Engineering, or related technical discipline required. Preferred: PhD or advanced degree with specialization relevant to vaccine/large molecule manufacture (or equivalent technical experience). Experience & skills
Minimum ~7 years’ relevant experience in vaccines, biologics, pharmaceutical, or related industries, spanning R&D, tech transfer, or commercial manufacturing support. Direct hands‑on experience planning and conducting freeze‑dry studies and assessing commercial lyophilization processes. Demonstrated capability in product and equipment characterization, process development, and scale‑up for lyophilization and aseptic fill‑finish. Strong written and verbal communication; proven ability to influence cross‑functional stakeholders and train technical teams. Familiar with change control, deviation management, protocol/report authorship, and regulatory license documentation. Preferred qualifications
Published papers, conference presentations, or recognized contributions in the domain of lyophilization. Experience working across both R&D and commercial manufacturing environments in Animal Health or human biologics. Required Skills
Aseptic Manufacturing, Aseptic Processing, Biologics, Driving Continuous Improvement, Drug Product Development, Fill and Finish, Formulation Optimization, Freeze Dry, Freeze Drying, Good Manufacturing Practices (GMP), Manufacturing, Manufacturing Operations, Manufacturing Scale-Up, Strategic Thinking, Technical Issues, Technical Problem-Solving, Technology Transfer, Vaccine Manufacturing Preferred Skills
Current employees may apply for opportunities within the company. Current contingent workers may apply for opportunities within the company. US and Puerto Rico Residents Only:
Our company is committed to inclusion and providing accommodations during the application or hiring process. If you need an accommodation, please indicate so. Equal Employment Opportunity : We provide equal opportunities to all employees and applicants and prohibit discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights pages. Hybrid Work Model U.S. Hybrid work model: three days on-site per week with Friday remote, with exceptions noted for field-based, facility-based, or remote-designated roles. Specific site requirements may vary. Salary and Benefits The salary range for this role is $126,500.00 - $199,100.00. This range reflects good faith estimates at posting time and depends on education, qualifications, experience, location, and business needs. The successful candidate will be eligible for annual bonus and long‑term incentives, if applicable. We offer a comprehensive benefits package. Application You can apply for this role at the company careers site. The application deadline is noted on the posting. End of Posting This job posting is effective until the listed end date or until it is closed; apply by the stated deadline.
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