Sr. Specialist, Bio Technology Solutions (BTS) - Site Support
Job description
Job Description
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.
Qualifications
Required
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
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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.
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The salary range for this role is
$117,000.00 - $184,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
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.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
Yes
Job Posting End Date:
09/30/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.