Merck
Sr. Specialist, Regional Projects Team
Our Animal Health Manufacturing 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. Your main field of attention is to provide technical support to Vaccine and Biopharmaceutical Manufacturing for commercial Animal Health products. The focus of an Sr. Specialist within the Regional Projects team in the BioTechnology Solutions (BTS) department is on Vaccine process evaluations/transfers in support of commercial antigen manufacturing and sterile fill-finish to produce liquid or lyophilized products. Within a multidisciplinary environment you will cooperate with your colleagues from BTS-Process Development, BTS-Site Support, BTS-Analytical, Operations, Site Engineering, Quality Control/Assurance, Supply Planning, Global Regulatory Affairs, Environmental Health and Safety, Research, Regional Transfer Task Force, and Regional Strategy teams. Leads and/or works independently to evaluate/transfer manufacturing processes for microbial, viral or cell cultures followed by purification/concentration, blending, and filling for liquid and lyophilized sterile veterinary vaccines and biopharmaceuticals (antibody therapeutics). Works at the speed of business to resolve manufacturing challenges while always ensuring timelines meet the requirements of the customer regarding safety, quality, cost-efficiency, practical applicability, and consistency. Whether working independently or in collaboration with other departments (e.g. Quality, Research, Production, BioTechnology Solutions
Analytical and/or Process Development), must ensure sound scientific data/literature/evaluation and integrity drives every decision/recommendation. Demonstrates working knowledge of current United States Department of Agriculture (USDA) regulatory guidelines. Develops project charters and project plans and align with all sponsors and stakeholders. Key capabilities include project management skills: development of timelines, use of project tracking tools, definition of deliverables, definition of roles and responsibilities, risk identification/tracking/mitigation and business acumen. Coordinates and tracks team activities by leading or participating in core team meetings, communicates project risks and status to appropriate stakeholders, and escalates challenges as well as opportunities to sponsors at the speed of the business need. Assures consistent application of standardized work, engineering controls, and process analytical technology. Authors experimental protocols and reports in support of laboratory or production scale evaluations. Creates and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation. Displays leadership behaviors and demonstrate a high emotional intelligence. Effectively collaborates with peers on site and among sites as required. Trains and guides other employees and/or interns. Performs off-shift work (only as needed). Education Minimum Requirement: Bachelor of Science in Chemical Engineering, Biotechnology, Mechanical Engineering, Biochemistry, or related field with at least 5 years of experience in vaccine Process/Product Development or closely related field. (Or Master of Science degree and at least 3 years of relevant work experience or a Doctoral degree.) Required Experience and Skills: Experience in sterile vaccine manufacturing process/product development and manufacturing, including process scale-up and qualification/validation with process analytical technology and appropriate analytical monitoring tools Working knowledge of USDA regulations Knowledge of requirements for manufacture and testing for sterile liquid and lyophilized vaccines Understanding statistics and application to process monitoring and control Excellent written and oral communication skills Excellent project management, documentation, and writing Excellent teamworking and collaboration skills Embraces diversity and promotes inclusion Strong problem-solving skills and a hands-on approach to solving problems inclusive of diverse perspectives (e.g. safety, compliance) Global Animal Health Manufacturing Division is committed to being the most trusted supplier of biopharmaceuticals 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.
Our Animal Health Manufacturing 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. Your main field of attention is to provide technical support to Vaccine and Biopharmaceutical Manufacturing for commercial Animal Health products. The focus of an Sr. Specialist within the Regional Projects team in the BioTechnology Solutions (BTS) department is on Vaccine process evaluations/transfers in support of commercial antigen manufacturing and sterile fill-finish to produce liquid or lyophilized products. Within a multidisciplinary environment you will cooperate with your colleagues from BTS-Process Development, BTS-Site Support, BTS-Analytical, Operations, Site Engineering, Quality Control/Assurance, Supply Planning, Global Regulatory Affairs, Environmental Health and Safety, Research, Regional Transfer Task Force, and Regional Strategy teams. Leads and/or works independently to evaluate/transfer manufacturing processes for microbial, viral or cell cultures followed by purification/concentration, blending, and filling for liquid and lyophilized sterile veterinary vaccines and biopharmaceuticals (antibody therapeutics). Works at the speed of business to resolve manufacturing challenges while always ensuring timelines meet the requirements of the customer regarding safety, quality, cost-efficiency, practical applicability, and consistency. Whether working independently or in collaboration with other departments (e.g. Quality, Research, Production, BioTechnology Solutions
Analytical and/or Process Development), must ensure sound scientific data/literature/evaluation and integrity drives every decision/recommendation. Demonstrates working knowledge of current United States Department of Agriculture (USDA) regulatory guidelines. Develops project charters and project plans and align with all sponsors and stakeholders. Key capabilities include project management skills: development of timelines, use of project tracking tools, definition of deliverables, definition of roles and responsibilities, risk identification/tracking/mitigation and business acumen. Coordinates and tracks team activities by leading or participating in core team meetings, communicates project risks and status to appropriate stakeholders, and escalates challenges as well as opportunities to sponsors at the speed of the business need. Assures consistent application of standardized work, engineering controls, and process analytical technology. Authors experimental protocols and reports in support of laboratory or production scale evaluations. Creates and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation. Displays leadership behaviors and demonstrate a high emotional intelligence. Effectively collaborates with peers on site and among sites as required. Trains and guides other employees and/or interns. Performs off-shift work (only as needed). Education Minimum Requirement: Bachelor of Science in Chemical Engineering, Biotechnology, Mechanical Engineering, Biochemistry, or related field with at least 5 years of experience in vaccine Process/Product Development or closely related field. (Or Master of Science degree and at least 3 years of relevant work experience or a Doctoral degree.) Required Experience and Skills: Experience in sterile vaccine manufacturing process/product development and manufacturing, including process scale-up and qualification/validation with process analytical technology and appropriate analytical monitoring tools Working knowledge of USDA regulations Knowledge of requirements for manufacture and testing for sterile liquid and lyophilized vaccines Understanding statistics and application to process monitoring and control Excellent written and oral communication skills Excellent project management, documentation, and writing Excellent teamworking and collaboration skills Embraces diversity and promotes inclusion Strong problem-solving skills and a hands-on approach to solving problems inclusive of diverse perspectives (e.g. safety, compliance) Global Animal Health Manufacturing Division is committed to being the most trusted supplier of biopharmaceuticals 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.