About this role
Job Description About the Organization The Biologics Science and Technology Platforms, Data, Modeling, and Statistics (PDSM) organization is a highly technical, science-forward function embedded within Bio S&T. We partner closely with manufacturing sites, IT, and process engineers to deliver data-driven process insights, statistical modeling, and digital capabilities that accelerate biologics commercialization and manufacturing excellence. Our mission is to bridge the gap between traditional process engineering and modern data science.
We build the foundational architectures, digital workflows, and analytical models that underpin every initiative across the biologics network—enabling proactive process monitoring (PPM), continued process verification (CPV), yield optimization, tech transfer, and AI-ready manufacturing. We work hand-in-hand with our IT and manufacturing partners to co-design process analytics platforms. Our team contributes deep bioprocessing domain understanding paired with technical data science capabilities, ensuring the right process parameters and quality attributes are captured, contextualized, and modeled to drive real operational outcomes.
Position Summary The Associate Director, Advanced Process Analytics & Data Strategy is a technical individual contributor role within PDSM. The primary expectation is hands-on technical contribution applying data science, process modeling, and data architecture to optimize biologics manufacturing. The successful candidate will act as a trusted technical expert, leveraging their bioprocess engineering background to build analytics solutions, drive process standardization, and partner closely with scientists and digital teams.
We are seeking candidates who fit the Domain-to-Data Professional profile: A bioprocess, biochemical, or regulated manufacturing engineer who has developed meaningful data science expertise through hands-on work with process, analytical, and batch data. You must be able to apply tools such as Python, R, SQL, and statistical modeling to support process characterization, digital analytics, root-cause investigations, and regulatory-ready manufacturing data products. Key Responsibilities 1.
Biologics Process Analytics & Engineering Strategy Define and drive an advanced process analytics roadmap focused on connecting unit operations (upstream/downstream), process parameters (CPPs), and quality attributes (CQAs) through enterprise data models. Act as the vital bridge between bioprocessing science and data technology—translating complex manufacturing process dynamics into data requirements, and translating data capabilities into scientific and operational value (e.g., yield improvement, cycle time reduction). Lead process-focused data initiatives, assembling cross-functional teams (engineers, scientists, IT) to implement advanced analytics and digital capabilities across biologics manufacturing workflows.
2. Manufacturing Data Architecture & Contextualization Build and maintain a clear data flow map across the biologics manufacturing network, integrating core manufacturing systems (MES, LIMS, PI Historian, SAP, ELN). Lead process data contextualization and ontology mapping.
Ensure raw process and analytical data is properly linked across unit operations, sites, and product lifecycle stages to enable seamless tech transfer and comparability studies. Partner with IT to co-design scalable, GxP-compliant data engineering solutions, providing the critical bioprocess domain context required to structure the data correctly for scientific use. Define and enforce data integrity specifications (ALCOA+) to ensure reliability and regulatory compliance across manufacturing data products.
3. Process Monitoring, Modeling & Statistical Enablement Develop and deploy fit-for-purpose dashboards, process visualizations, and analytics to enable Proactive Process Monitoring (PPM), trend identification, and rapid root-cause investigation support. Partner with the Statistical Sciences (CMS) and Process/Product Modeling teams to ensure the underlying data foundation robustly supports Continued Process Verification (CPV), digital twins, AI/ML models, and multivariate analysis.
Collaborate with internal manufacturing sites and Contract Manufacturing Organizations (CMOs) to establish sustainable data access and improve the usability of process/analytical data for technical troubleshooting. 4. Process Governance & Standardization Establish process data standards, nomenclature, and data ownership models across the biologics network to enable cross-site comparability and AI readiness.
Build data stewardship practices that are owned and sustained by the engineering and science teams, ensuring data governance is treated as a core manufacturing capability. 5. Stakeholder Engagement & Capability Building Drive alignment across Technical Product Managers, process SMEs, Quality, Regulatory Affairs, and IT to advance shared process-analytics priorities.
Build digital and data literacy across Bio S&T by coaching peers, sharing engineering-focused use cases, and enabling governed self-service analytics through templates and training. Education Requirements B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Life Sciences, or a related field with 8+ years of relevant biopharmaceutical experience. M.S. in the same fields with 6+ years of relevant experience, or Ph.D. with 4+ years of relevant experience.
Required Experience and Skills Bioprocess Engineering & Domain Expertise Strong foundational knowledge of biologics manufacturing (Upstream/Downstream unit operations, scale-up, tech transfer) and process characterization. Proven experience utilizing process data (PI Historian, MES, LIMS) to troubleshoot manufacturing issues, monitor process performance, or support regulatory filings. Deep understanding of GMP/GxP environments, Continued Process Verification (CPV), and quality/compliance requirements in biomanufacturing.
Data Science & Technical Engineering Hands-on experience with Python or R for data manipulation, statistical analysis, and scripting—applied specifically to scientific or manufacturing datasets. Moderate to strong hands-on SQL skills; ability to query, transform, and validate data across relational databases. Understanding of how to extract and structure time-series data (e.g., from PI/DeltaV) and relational batch data to build actionable process models.
Familiarity with data architecture concepts (data lakes, data warehousing) and experience collaborating with IT/Data Engineering to operationalize analytical pipelines. Leadership, Strategy, and Communication Strategic thinking and independent execution capability — ability to define a data strategy roadmap and drive hands-on delivery against it without requiring a team to execute beneath you. Proven ability to influence without authority and drive alignment across technical, business, Digital, Quality, and external partner stakeholders.
Strong change management skills — ability to drive adoption of new data practices and tools across a complex, globally distributed organization. Ability to translate complex technical and data concepts into clear, actionable recommendations for both technical and non-technical audiences. Comfortable operating in ambiguity and early-stage capability building — able to define the right approach before executing it.
Track record of operating as a trusted technical expert and advisor within cross-functional teams — coaching and sharing knowledge without formal authority. Preferred Experience and Skills Experience with biologics manufacturing data systems and the specific data challenges associated with bioprocess scale-up, tech transfer, and commercial manufacturing. Familiarity with data platform and mapping standards, OSIsoft PI / PI AF, Seeq, Power BI, Spotfire, Dataiku, JMP, AWS, Databricks.
Background in PPM, CPV, investigation support analytics, cross-site process robustness analysis, or statistical process control in a GMP environment. Experience with external manufacturing data exchange — partnering with CMOs and external sites to establish governed data access and contextualization. Experience building or scaling a data function within a science or manufacturing organization — including hiring, developing, and organizing a team around a clear data strategy mission.
Experience with master data management or semantic data models that support cross-system comparability and reuse. Track record of influencing senior leadership and cross-functional partners on data strategy priorities and investment decisions. Why Join PDSM This is a rare opportunity to build something foundational.
PDSM is in the early stages of creating a truly integrated data and digital capability for biologics commercialization — and the Data Strategy function is at the center of that work. You will: Shape the data architecture and governance framework that underpins Bio S&T’s entire digital and analytics agenda. Work at the intersection of pharmaceutical manufacturing science and cutting-edge data and digital capabilities.
Partner with a high-performing, mission-driven team across PDSM, Digital, IT, and the broader Bio S&T organization. Contribute directly to accelerating how transformative medicines reach patients — faster, smarter, and with greater scientific confidence. Ability to travel up to 15%.
Required Skills: Automation Systems, Change Management, Dashboard Development, Data Access, Data Analysis, Data Governance, Data Integrity, Data Management, Data Mapping, Data Science, Data Standards, Data Stewardship, Drug Product Manufacturing, Manufacturing Scale-Up, Master Data, Regulatory Compliance, Root Cause Analysis (RCA), SQL Databases, Strategic Thinking, Technical Transfer, TIBCO Spotfire, Use Cases Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. 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: EEOC Know Your Rights EEOC GINA Supplement 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 The salary range for this role is $142,400.00 - $224,100.00 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.
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Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 09/23/2026 *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.