As part of Our Company’s Manufacturing Division, within the Vaccines Drug Substance Commercialization (VDSC), the Upstream department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for the upstream portion of vaccines drug substance processes VDSC supports various commercialization activities, early and late stage process development, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions

• We are seeking individual contributors with strong scientific and technical skills to lead development and commercialization activities supporting multiple vaccine programs in late stage development
• Leading and executing large molecule upstream process development activities including lab-scale process development and process scale-up/scale-down
• Executing lab scale experiments and authoring associated technical reports and documents
• Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner
• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure
• Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within our Company's network and at contract manufacturing organizations (CMOs)
• Providing mentorship, coaching, and technical direction to other members of the team which may include direct reporting relationships

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Master's degree with 4+ years of relevant experience; or Ph.D. with relevant experience
• Required Experience And Skills
• Large molecule process development, or relevant experience including scaling (up and down) and tech transfer/facility fit of large molecule drug substance processes
• Good understanding of microbial physiology and metabolism and ability to correlate to in-lab or shop floor fermentation events
• Experience with authoring technical documentation
• Outstanding communication and people skills
• Ability to foster a collaborative work environment focused on mentorship, coaching, and learning
• Experience with project strategic planning
• 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

Valid Driving License

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 6+ years of relevant experience; or
• Experience with small, lab, or pilot-scale large molecule fermentation and cell culture processes such as use of fermentors, bioreactors, and/or static cell culture
• Expertise in lab scale experimental execution and experience with statistical data analysis (JMP, PI Vision, Spotfire, SIMCA, etc.) including presentation of results/conclusions

Accountability, Adaptability, Biochemistry, Biomedical Engineering, Biopharmaceuticals, Bioreactors, Cell Cultures, cGMP Regulations, Chemical Engineering, Design of Experiments (DOE), Detail-Oriented, GMP Compliance, Good Manufacturing Practices (GMP), Innovation, Mammalian Cell Culture, Microbiology, Process Design, Process Optimization, Process Scale Up, Production Process Development, Strategic Planning, Technical Writing Documentation, Technology Transfer

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits

No relocation