Sr. Specialist, Bio Technology Solutions (BTS) - Site Support

Welcome to our 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. We work in local and regional manufacturing facilities connected to our global network to ensure the highest quality of raw materials, intermediates, and finished products. Join us to be at the forefront of delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Responsibilities

• Lead and work independently on the optimization, troubleshooting, and lifecycle management of commercial manufacturing processes involving microbial, viral, or cell culture production, downstream purification, concentration, formulation, and sterile fill-finish operations for veterinary vaccines and biopharmaceutical products.
• Serve as a technical leader for complex manufacturing investigations, providing scientific direction and risk-based decision making to resolve production challenges while maintaining compliance, product quality, and supply continuity.
• Lead technology transfer activities within and between manufacturing sites, ensuring successful transfer of process knowledge, manufacturing readiness, and process performance.
• Partner with Operations, Engineering, Quality, Regulatory, and Supply Chain organizations to resolve technical issues at the speed of business while ensuring solutions meet safety, quality, compliance, cost, and operational requirements.
• Lead cross-functional teams in process improvement, validation, process characterization, change control, and manufacturing robustness initiatives.
• Evaluate manufacturing challenges from multiple perspectives including process design, equipment performance, automation, compliance, quality systems, and human performance to determine root cause and implement effective corrective actions.
• Provide scientific leadership during deviations, investigations, CAPAs, and regulatory inspections by ensuring decisions are supported by sound science, data analysis, technical expertise, and regulatory expectations.
• Develop, implement, and evaluate new technologies, manufacturing platforms, process analytical technologies, and automation solutions to improve process capability and operational efficiency.
• Collaborate closely with BTS Process Development, Analytical Sciences, and Research organizations to support new product introductions, process transfers, scale-up activities, and commercialization initiatives.
• Demonstrate advanced knowledge of USDA and applicable regulatory requirements and apply those requirements to manufacturing processes, investigations, validations, and change management activities.
• Support inspection readiness efforts and provide technical expertise during internal audits and regulatory inspections.
• Lead project planning activities including development of project charters, timelines, resource planning, risk assessments, stakeholder alignment, and communication strategies.
• Manage multiple technical projects simultaneously and provide regular updates on progress, risks, mitigation plans, and strategic recommendations to site and divisional leadership.
• Ensure consistent application of standardized work processes, process control strategies, engineering controls, and manufacturing best practices.
• Design, execute, and interpret laboratory- and manufacturing-scale studies to support process improvements, investigations, technology implementation, and validation activities.
• Author and approve technical protocols, study reports, validation documents, technical assessments, process monitoring strategies, and manufacturing documentation.
• Develop and maintain process knowledge through statistical analysis, process monitoring, trend evaluation, and data-driven decision making.
• Contribute to global BTS initiatives and collaborate with international teams to share technical knowledge, best practices, and lessons learned across the network.
• Demonstrate company leadership behaviors and serve as a technical mentor for specialists, engineers, interns, and early-career employees.
• Drive continuous improvement initiatives supporting operational excellence, safety performance, environmental stewardship, and manufacturing reliability.
• Perform off-shift support as required to support manufacturing operations and critical business needs.

• Bachelor’s Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, Biology, Microbiology, Protein Chemistry, Mechanical Engineering, or a related scientific or engineering discipline with a minimum of 5 years of experience in vaccine and/or biopharmaceutical development, process development, technical support, technology transfer, process engineering, or biological manufacturing
• OR Master’s Degree with a minimum of 3 years of relevant experience
• Excellent written and verbal communication skills
• Strong technical writing and documentation capabilities
• Demonstrated project leadership and project management experience
• Ability to lead cross-functional teams and influence stakeholders across organizational levels
• Strong scientific and engineering problem-solving skills
• Experience leading manufacturing investigations and root cause analyses
• Ability to work effectively in multidisciplinary and global teams
• Strong data analysis and critical thinking capabilities
• Demonstrated ability to make risk-based decisions in a regulated manufacturing environment
• Commitment to safety, quality, compliance and inclusion
• Ability to mentor and develop technical team members

Preferred

• Experience supporting commercial vaccine and/or biopharmaceutical manufacturing
• Technical expertise in microbial fermentation, viral propagation, cell culture, purification, filtration, formulation, and sterile manufacturing processes
• Experience with process validation, technology transfer, and process lifecycle management
• Working knowledge of USDA regulations and expectations
• Knowledge of GMP requirements for manufacturing and testing of biologic products
• Understanding of process monitoring, statistical analysis, and statistical process control
• Experience with change management systems, deviations, CAPAs, and regulatory inspections
• Experience implementing process analytical technologies, automation solutions, or advanced manufacturing technologies

Required Skills:

Communication, Cross-Functional Collaboration, Downstream Manufacturing, Downstream Processing, Laboratory Processes, Manufacturing Production, Sterile Manufacturing, Technical Leadership, Technology Transfer, USDA Regulations

Preferred Skills:

Coaching Others, Coach Team Members, Facilitation, Relationship Building

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

The salary range for this role is

$117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.