Merck
Senior Process Development Scientist - Bioconjugation & Commercialization
Merck, West Point, Pennsylvania, us, 19486
Job Posting
As part of Our Company's Manufacturing Division, within the Vaccine Drug Substance Commercialization (VDSC), the Bioconjugation and Chemistry (BCC) team provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for biologically derived drug substances (e.g., therapeutic proteins, antibody drug conjugates, or vaccines) generated from bioconjugation processes. For late-stage pipeline commercialization, activities include process characterization, technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring. This role may require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing. This role may also require approximately 25% of time spent on domestic (e.g. to Rahway, NJ site) or international travel. In this role, the successful candidate will be responsible for: Technical leadership on design, planning, and executing laboratory experiments and investigations for the purposes of mechanistic understanding and to enable process development, problem solving, and to reduce risk inherent in scale up or scale down of drug substance / bioconjugation processes. Responsible for planning or executing scale studies to support commercial process validation, process characterization, and investigation evaluations, including studies performed either in-house or externally. Design, plan, and execute laboratory experiments to generate high quality data. Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports. Authors experimental protocols and documents work in a lab notebook. Documents lab activities, findings and conclusions in scientific reports, and presents knowledge at appropriate forums. Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations. May be responsible for managing multifaceted projects as the leader of a cross-functional team. As an individual contributor, may be concerned with clearly identifiable elements or functions within a larger project team. Education & Experience: Bachelor's Degree in Engineering, Science, or related field with a minimum of four (4) years of large molecule/anti-body drug conjugate and/or commercialization experience; OR Master's Degree with a minimum of three (3) years of large molecule/anti-body conjugate experience; OR Doctoral Degree (Ph.D.) with no (0) years of experience. Required Skills and Experience: Experience with large molecule manufacturing processes including on-the-floor GMP manufacturing support Experience designing process development experiments using risk-based methodology or similar Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions such as BLAs, INDs, or other regulatory source documentation Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors Possesses outstanding communication skills Ability to coach others and manage small teams effectively Preferred Skills and Experience: Experience with bioconjugation or antibody drug conjugate processes Experience interacting with and overseeing commercialization activities at both internal and external manufacturing sites Experience with process scale-up and/or technology transfer, moving from laboratory to pilot plant or production scale or similar
As part of Our Company's Manufacturing Division, within the Vaccine Drug Substance Commercialization (VDSC), the Bioconjugation and Chemistry (BCC) team provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for biologically derived drug substances (e.g., therapeutic proteins, antibody drug conjugates, or vaccines) generated from bioconjugation processes. For late-stage pipeline commercialization, activities include process characterization, technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring. This role may require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing. This role may also require approximately 25% of time spent on domestic (e.g. to Rahway, NJ site) or international travel. In this role, the successful candidate will be responsible for: Technical leadership on design, planning, and executing laboratory experiments and investigations for the purposes of mechanistic understanding and to enable process development, problem solving, and to reduce risk inherent in scale up or scale down of drug substance / bioconjugation processes. Responsible for planning or executing scale studies to support commercial process validation, process characterization, and investigation evaluations, including studies performed either in-house or externally. Design, plan, and execute laboratory experiments to generate high quality data. Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports. Authors experimental protocols and documents work in a lab notebook. Documents lab activities, findings and conclusions in scientific reports, and presents knowledge at appropriate forums. Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations. May be responsible for managing multifaceted projects as the leader of a cross-functional team. As an individual contributor, may be concerned with clearly identifiable elements or functions within a larger project team. Education & Experience: Bachelor's Degree in Engineering, Science, or related field with a minimum of four (4) years of large molecule/anti-body drug conjugate and/or commercialization experience; OR Master's Degree with a minimum of three (3) years of large molecule/anti-body conjugate experience; OR Doctoral Degree (Ph.D.) with no (0) years of experience. Required Skills and Experience: Experience with large molecule manufacturing processes including on-the-floor GMP manufacturing support Experience designing process development experiments using risk-based methodology or similar Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions such as BLAs, INDs, or other regulatory source documentation Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors Possesses outstanding communication skills Ability to coach others and manage small teams effectively Preferred Skills and Experience: Experience with bioconjugation or antibody drug conjugate processes Experience interacting with and overseeing commercialization activities at both internal and external manufacturing sites Experience with process scale-up and/or technology transfer, moving from laboratory to pilot plant or production scale or similar